BD Cathena Safety IV Catheter 386806Recalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 00382903868063), received between Sep 6, 2018 and Aug 20, 2025 — classified as 4 injuries, 68 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (38 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 72 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT BD CATHENA 22GX1.00IN STRAIGHT BC - FOREIGN MATTER. MATERIAL: 386806. BATCH#: 4304898. IT WAS REPORTED BY THE CUSTOMER THAT THERE IS SOME SORT OF PLASTIC OR ADHESIVE THAT IS COMING OFF THE INJECTION PART OF THE NEEDLE. WE HAVE CHECKED MULTIPLE NEEDLES WITH THIS LOT NUMBER AND THE ISSUE IS PRESENT WITH MOST OF THE NEEDLES. NO ISSUES WITH OTHER LOTS AT THIS POINT. THE LITTLE PIECES ARE TOO DIFFICULT TO GET A PICTURE OF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22850615 ↗
• MalfunctionAug 1, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT BD CATHENA 22GX1.00IN STRAIGHT BC CATHETER WAS DEFECTIVE / DAMAGED IT WAS REPORTED BY THE CUSTOMER THAT CATHETER USED ON A PATIENT HAS AN END THAT APPEARS FRAYED. THEY QUESTIONED THE SAFETY OF THIS CATHETER, AS A SMALL PIECE OF MATERIAL COULD COME OFF AND BE DANGEROUS FOR THE PATIENT. VERBATIM: A NURSE IN THE ENDOSCOPY DEPARTMENT IN THE RECOVERY ROOM REPORTS THAT A CATHETER USED ON A PATIENT HAS AN END THAT APPEARS FRAYED. HE QUESTIONED THE SAFETY OF THIS CATHETER, AS A SMALL PIECE OF MATERIAL COULD COME OFF AND BE DANGEROUS FOR THE PATIENT. THE CATHETER IS BEING KEPT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22693118 ↗
• MalfunctionJul 22, 2025Material Perforation; Material Perforation

  IT WAS REPORTED THAT BD CATHENA 22GX1.00IN STRAIGHT BC NEEDLE WENT THROUGH THE CATHETER DURING CANNULATION OF PT, NEEDLE PERFORATED PLASTIC TUBING SNAPPED /PIERCED THROUGH. UNABLE TO CONTINUE I/C CANNULATION. PROCEDURE ABANDONED. BLOOD FLOWING ++.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22566521 ↗
• MalfunctionJul 9, 2025Contamination; Contamination /Decontamination Problem; Contamination; Contamination /Decontamination Problem

  IT WAS REPORTED THAT BD CATHENA 22GX1.00IN STRAIGHT BC HAD FOREIGN MATTER OTHER INCIDENTS WITH OTHER CODES - INVESTIGATED 22G AND FOUND SIMILAR ISSUE. WA HEALTH INCIDENT REPORT # - (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22459424 ↗
• MalfunctionMay 15, 2025Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE BD CATHENA 22GX1.00IN STRAIGHT BC HAD A NEEDLE RETRACTION FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 386806, BATCH#: 4205838. RCC RECEIVED A COMPLAINT VIA EMAIL. NEW REPORT OF DISSATISFACTION FROM ONE OF OUR CARE TEAMS, IN CONNECTION WITH THE PRODUCT: 386806, BATCH: 4205838. SIMILAR COMPLAINT FROM ANOTHER DEPARTMENT ON (B)(4). COMMENTS ON THE CURRENT COMPLAINT RECEIVED: SUMMARY DESCRIPTION OF THE PROBLEM ENCOUNTERED: SEVERAL DEFECTIVE CATHETERS, CONTROL OF THE NON-FUNCTIONAL VENOUS RETURN SO BLOOD FLOWS EVERYWHERE AND NEEDLE PROTECTION SYSTEM, THE RETRACTION SYSTEM DOES NOT WORK PROBLEM FREQUENCY: FREQUENTLY. IMPACT OF THE PROBLEM: DANGEROUS TO PRICK WITH NEEDLES AND TO CONTAMINATE YOURSELF WITH BLOOD. ANSWERS TO THE QUESTIONS YOU USUALLY ASK: PLEASE DESCRIBE THE ISSUE THAT IS THE SUBJECT OF YOUR REPORT IN MORE DETAIL. THE PROBLEM IS THE SAME AS WHAT IS DESCRIBED IN THE REPORT. (VENOUS RETURN CONTROL PROBLEM AND CATHETER NEEDLE DOES NOT RETRACT. 2. WHAT WAS THE IMPACT OF THE INCIDENT ON THE PATIENT? IMPACT ON NURSING. 3. DID THE PROBLEM OCCUR WHILE USING THE PRODUCT IN A PATIENT? YES, WE INSTALL A VENOUS LINE! WAS TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22024885 ↗
• MalfunctionMay 15, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD CATHENA 22GX1.00IN STRAIGHT BC HAD LEAKAGE OUT OF THE CONTROL PLUG. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 386806 AND BATCH#: 4205838. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. NEW REPORT OF DISSATISFACTION FROM ONE OF OUR CARE TEAMS, IN CONNECTION WITH THE PRODUCT 386806, BATCH 4205838. SIMILAR COMPLAINT FROM ANOTHER DEPARTMENT ON (B)(6). -COMMENTS ON THE CURRENT COMPLAINT RECEIVED: SUMMARY DESCRIPTION OF THE PROBLEM ENCOUNTERED: SEVERAL DEFECTIVE CATHETERS, CONTROL OF THE NON-FUNCTIONAL VENOUS RETURN SO BLOOD FLOWS EVERYWHERE AND NEEDLE PROTECTION SYSTEM, THE RETRACTION SYSTEM DOES NOT WORK. PROBLEM FREQUENCY: FREQUENTLY. IMPACT OF THE PROBLEM: DANGEROUS TO PRICK WITH NEEDLES AND TO CONTAMINATE YOURSELF WITH BLOOD. -ANSWERS TO THE QUESTIONS YOU USUALLY ASK: PLEASE DESCRIBE THE ISSUE THAT IS THE SUBJECT OF YOUR REPORT IN MORE DETAIL. THE PROBLEM IS THE SAME AS WHAT IS DESCRIBED IN THE REPORT. (VENOUS RETURN CONTROL PROBLEM AND CATHETER NEEDLE DOES NOT RETRACT. 2. WHAT WAS THE IMPACT OF THE INCIDENT ON THE PATIENT? IMPACT ON NURSING. 3. DID THE PROBLEM OCCUR WHILE USING THE PRODUCT IN A PATIENT? YES, WE INSTALL A V

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22023773 ↗
• MalfunctionApr 25, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT BD CATHENA 22GX1.00IN STRAIGHT BC NEEDLE WENT THROUGH THE CATHETER PHONE CALL RECEIVED FORM XXXX REGARDING ANOTHER INCIDENT WITH CATHENA IVCS, THIS TIME A 22G. REPORTED THAT A 22G CATHENA WAS PLACED INTO A PATIENT'S ARM IN DOSA DEPARTMENT AND THAT THE CLINICIAN HAD DIFFICULTY ADVANCING THE IVC INTO THE PATIENT- SAID "FELT STUCK". UPON REMOVAL (AS COULD NOT USE), DISCOVERED THE NEEDLE WAS POKING THROUGH THE SIDE OF THE CATHENA. PATIENT REQUIRED NEW INSERTION OF CATHENA IVC, NO DELAY TO TREATMENT. XXXXX REPORTED INITIALLY THAT THE STICKTION WAS NOT RELEASED BY LOOSENING THE IVC, BUT LATER CALLED TO INFORMED THAT THEY DID AND THAT SHE BELIEVES IS USER ERROR. SAMPLE RETAINED AND AVAILABLE FOR COLLECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21911074 ↗
• MalfunctionMar 25, 2025Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT BD CATHENA 22GX1.00IN STRAIGHT BC NEEDLE RETRACTION FAILED NEEDLE GETS STUCK. DURING USE. AFTER INSERTION AND CANNULATION INTO THE VEIN, WHEN STABILISING THE CATHETER AND ATTEMPTING TO REMOVE THE NEEDLE, THE NEEDLE GETS STUCK AND A LOT OF PRESSURE HAS TO BE APPLIED TO REMOVE THE NEEDLE. THE NURSING STAFF, FROM THE DAY HOSPITAL UNIT, HAS NOTIFIED US OF INCIDENTS THAT HAVE OCCURRED OVER THE LAST 15 DAYS, WHEN ATTEMPTING TO CANNULATE PERIPHERAL VENOUS LINES IN 3 PATIENTS. IT HAS BEEN DETECTED IN 3 PERIPHERAL VENOUS CATHETERS (CVP) NUMBER 22 (0.9X25MM) FROM THE COMMERCIAL COMPANY "BD CATHENA", CORRESPONDING TO LOT 4096507, THAT AFTER INSERTION AND CANNULATION IN THE VEIN, WHEN STABILISING THE CATHETER AND TRYING TO REMOVE THE NEEDLE, IT GETS STUCK, HAVING TO EXERT GREAT PRESSURE TO REMOVE IT. AS A PRECAUTIONARY MEASURE, WE HAVE REMOVED THE REMAINING 15CVP STORED IN THE UNIT, CORRESPONDING TO THAT BATCH, AND NEW BATCH HAS BEEN USED. THE HOSPITAL WAREHOUSE HAS BEEN NOTIFIED TO CONFIRM THAT NO MORE BOXES WITH THE SAME BATCH NUMBER ARE STORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21688471 ↗
• MalfunctionMar 25, 2025Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT BD CATHENA 22GX1.00IN STRAIGHT BC NEEDLE RETRACTION FAILED NEEDLE GETS STUCK DURING USE AFTER INSERTION AND CANNULATION INTO THE VEIN, WHEN STABILISING THE CATHETER AND ATTEMPTING TO REMOVE THE NEEDLE, THE NEEDLE GETS STUCK AND A LOT OF PRESSURE HAS TO BE APPLIED TO REMOVE THE NEEDLE. THE NURSING STAFF, FROM THE DAY HOSPITAL UNIT, HAS NOTIFIED US OF INCIDENTS THAT HAVE OCCURRED OVER THE LAST 15 DAYS, WHEN ATTEMPTING TO CANNULATE PERIPHERAL VENOUS LINES IN 3 PATIENTS. IT HAS BEEN DETECTED IN 3 PERIPHERAL VENOUS CATHETERS (CVP) NUMBER 22 (0.9X25MM) FROM THE COMMERCIAL COMPANY "BD CATHENA", CORRESPONDING TO LOT 4096507, THAT AFTER INSERTION AND CANNULATION IN THE VEIN, WHEN STABILISING THE CATHETER AND TRYING TO REMOVE THE NEEDLE, IT GETS STUCK, HAVING TO EXERT GREAT PRESSURE TO REMOVE IT. AS A PRECAUTIONARY MEASURE, WE HAVE REMOVED THE REMAINING 15CVP STORED IN THE UNIT, CORRESPONDING TO THAT BATCH, AND NEW BATCH HAS BEEN USED. THE HOSPITAL WAREHOUSE HAS BEEN NOTIFIED TO CONFIRM THAT NO MORE BOXES WITH THE SAME BATCH NUMBER ARE STORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21688470 ↗
• MalfunctionMar 25, 2025Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT BD CATHENA 22GX1.00IN STRAIGHT BC NEEDLE RETRACTION FAILED NEEDLE GETS STUCK. DURING USE AFTER INSERTION AND CANNULATION INTO THE VEIN, WHEN STABILISING THE CATHETER AND ATTEMPTING TO REMOVE THE NEEDLE, THE NEEDLE GETS STUCK AND A LOT OF PRESSURE HAS TO BE APPLIED TO REMOVE THE NEEDLE. THE NURSING STAFF, FROM THE DAY HOSPITAL UNIT, HAS NOTIFIED US OF INCIDENTS THAT HAVE OCCURRED OVER THE LAST 15 DAYS, WHEN ATTEMPTING TO CANNULATE PERIPHERAL VENOUS LINES IN 3 PATIENTS. IT HAS BEEN DETECTED IN 3 PERIPHERAL VENOUS CATHETERS (CVP) NUMBER 22 (0.9X25MM) FROM THE COMMERCIAL COMPANY "BD CATHENA", CORRESPONDING TO LOT 4096507, THAT AFTER INSERTION AND CANNULATION IN THE VEIN, WHEN STABILISING THE CATHETER AND TRYING TO REMOVE THE NEEDLE, IT GETS STUCK, HAVING TO EXERT GREAT PRESSURE TO REMOVE IT. AS A PRECAUTIONARY MEASURE, WE HAVE REMOVED THE REMAINING 15CVP STORED IN THE UNIT, CORRESPONDING TO THAT BATCH, AND NEW BATCH HAS BEEN USED. THE HOSPITAL WAREHOUSE HAS BEEN NOTIFIED TO CONFIRM THAT NO MORE BOXES WITH THE SAME BATCH NUMBER ARE STORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21688461 ↗
• MalfunctionMar 5, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD CATHENA 22GX1.00IN STRAIGHT BC BLOOD LEAKS OUT OF CONTROL PLUG WHILST IN MRI DEPARTMENT GIVING EDUCATION ON IAGBC PRO STAFF MRT MENTIONED THAT SHE HAD NOTED THAT CATHENA 22G WAS BLEEDING BACK INTO THE HUB, NOT GIVING BLOOD CONTROL PROTECTION. THIS HAPPENED ON THE 17TH FEBRUARY, BUT SHE HAD ALSO NOTICED THIS THE WEEK PRIOR. SHE MENTIONED THAT ANOTHER COLLEAGUE HAD NOTICED THIS PREVIOUSLY ALSO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21527703 ↗
• MalfunctionMar 5, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD CATHENA 22GX1.00IN STRAIGHT BC BLOOD LEAKS OUT OF CONTROL PLUG WHILST IN MRI DEPARTMENT GIVING EDUCATION ON IAGBC PRO STAFF MRT MENTIONED THAT SHE HAD NOTED THAT CATHENA 22G WAS BLEEDING BACK INTO THE HUB, NOT GIVING BLOOD CONTROL PROTECTION. THIS HAPPENED ON THE 17TH FEBRUARY, BUT SHE HAD ALSO NOTICED THIS THE WEEK PRIOR. SHE MENTIONED THAT ANOTHER COLLEAGUE HAD NOTICED THIS PREVIOUSLY ALSO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21527577 ↗
• MalfunctionNov 19, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD CATHENA 22GX1.00IN STRAIGHT BC LEAKED AT CATHETER JUNCTION LEAKAGE AT THE CONNECTION POINT BETWEEN CANNULA AND CATHETER DURING USE AFTER USE OF THE DEVICE ON THE PATIENT IT IS OBSERVED THAT THERE IS LEAKAGE AT THE JOINT OF THE CONE WITH THE CANNULA. OBSERVED DURING INFUSION. CATHETER ALLOWS BLOOD TO BE DRAWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20730053 ↗
• MalfunctionOct 3, 2024Activation Problem; Activation Problem

  IT WAS REPORTED THAT BD CATHENA 22GX1.00IN STRAIGHT BC NEEDLE RETRACTION FAILED. IT WAS REPORTED BY CUSTOMER THAT CUSTOMER INSERTED THE CATHETER AND WHEN WITHDRAWING THE NEEDLE, THE SECURITY MECHANISM DID NOT ENGAGE TO COVER THE NEEDLE TIP. (PLEASE SEE PICTURE). VERBATIM: COMPLAINT RECEIVED VIA EMAIL(S) ATTACHED. CUSTOMER INSERTED THE CATHETER AND WHEN WITHDRAWING THE NEEDLE, THE SECURITY MECHANISM DID NOT ENGAGE TO COVER THE NEEDLE TIP. (PLEASE SEE PICTURE).

  Patient problems: Insufficient Information

  MAUDE report 20364437 ↗
• MalfunctionJul 3, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD CATHENA 22GX1.00IN STRAIGHT BC LEAKED . IT WAS REPORTED BY THE CUSTOMER THAT PATIENT PIV TO R ACF NOTED TO BE LEAKING BY NURSE, SAME WAS FLUSHED AND CONTINUED TO LEAK, IV REMOVED AS SAME WAS LEAKING. DISCOVERED A WOUND AT THE INSERTION SITE OF THE IV, AS WELL AS TWO PRESSURE WOUNDS ABOVE AND LATERAL TO INSERTION SIDE, AND BELOW AND MEDIAL. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. AHS MDIP REFERENCE NUMBER (ID): (B)(4). DATE OF INCIDENT (YYYY-MM-DD): 2024-01-09 SITE NAME/LOCATION: XXXX LEVEL OF HARM: MINIMAL HARM AHS OPTIONAL REPORT TO CMDSNET (HEALTH CANADA): YES INCIDENT DETAILS: PATIENT PIV TO R ACF NOTED TO BE LEAKING BY NURSE, SAME WAS FLUSHED AND CONTINUED TO LEAK, IV REMOVED AS SAME WAS LEAKING. DISCOVERED A WOUND AT THE INSERTION SITE OF THE IV, AS WELL AS TWO PRESSURE WOUNDS ABOVE AND LATERAL TO INSERTION SIDE, AND BELOW AND MEDIAL. IMPACT OF INCIDENT: PAIN, DISCOMFORT. IV WAS REMOVED, CATHETER INTACT, PT SKIN CLEANED WITH NORMAL SALINE AND COVERED WITH A 2X2 GAUZE AND TAPE. WHO WAS AFFECTED? PATIENT DEVICE INFORMATION DEVICE NAME/DESCRIPTION: CATHETER IV SAFETY NON-WINGED WITH MULTIGUARD 22GAX1.00IN CATHENA MANUFACTURER: XXXX

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19666992 ↗
• MalfunctionApr 1, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BD CATHENA LEAKED PAST THE BC VALVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT DID NOT STOP BLEEDING AS IT IS SUPPOSE TO AND SHE COULD NOT ATTACH A IV BANG EITHER. WE HAD TO REMOVE IT UNFORTUNATELY AND RE INSERT A NEW ONE USING OLD CANULA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19015299 ↗
• MalfunctionAug 8, 2023Break; Break

  IT WAS REPORTED THAT THE BD CATHENA¿ SAFETY IV CATHETER WITH BD MULTIGUARD¿ TECHNOLOGY WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: THE CATHETER BROKE DURING INSERTION. DURING THE INSERTION OF THE DEVICE, WHEN MOVING THE CATHETER ITSELF OVER THE NEEDLE TO CANNULATE IT INTO THE VEIN, WITHOUT ANY OTHER MANIPULATION, A RESISTANCE WAS NOTICED AND WHEN THE DEVICE WAS REMOVED THE PLASTIC TUBE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17484682 ↗
• MalfunctionAug 3, 2023Material Separation; Material Separation

  IT WAS REPORTED WHILE USING BD CATHENA¿ SAFETY IV CATHETER WITH BD MULTIGUARD¿ TECHNOLOGY THE CATHETER DISCONNECTED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: THE DEVICES CONNECTED TO THE CATHETER DISCONNECT AFTER A PERIOD OF TIME. USUALLY, WITH THE PASSAGE OF HOURS OR DAYS, THE DEVICES CONNECTED TO THE CATHETER CONE (NEEDLELESS CONNECTORS, 3-WAY KEYS.) DISCONNECT SPONTANEOUSLY. THIS HAPPENS WITH ALL CATHETERS: ALL SIZES, LENGTHS AND LOTS - RELATED RECORDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17455867 ↗
• MalfunctionAug 2, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD CATHENA¿ SAFETY IV CATHETER WITH BD MULTIGUARD¿ TECHNOLOGY EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: LEAKAGE AT INSERTION SIDE: "IT IS REPORTED THAT AFTER INSERTION OF THE CATHETER THE INSERTION SITE IS VERY DILATED, WHICH EVEN CAUSES THE MEDICATION TO LEAK OUT ALMOST UNNOTICED.

  Patient problems: Vasculitis

  MAUDE report 17447389 ↗
• MalfunctionAug 2, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT 50 OF THE BD CATHENA¿ SAFETY IV CATHETER WITH BD MULTIGUARD¿ TECHNOLOGY EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: DEVICES CONNECTED TO THE CATHETER ARE DISCONNECTED AFTER A PERIOD OF TIME."

  Patient problems: Vasculitis

  MAUDE report 17447000 ↗
• MalfunctionAug 2, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THE BD CATHENA¿ SAFETY IV CATHETER WITH BD MULTIGUARD¿ TECHNOLOGY WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: AFTER SUCCESSFUL INSERTION, IF BLOOD COLLECTION IS REQUIRED, IT IS NECESSARY TO REMOVE PART OF THE CATHETER.

  Patient problems: Vasculitis

  MAUDE report 17446999 ↗
• MalfunctionAug 1, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 10 BD CATHENA¿ SAFETY IV CATHETER WITH BD MULTIGUARD¿ EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: END USERS POTENTIALLY EXPOSED TO BLOOD(STAFF PINCHING OFF CATHETER TO MINIMIZE RISK OF BLOOD EXPOSURE) AS CATHENA IS MISSING BLOOD CONTROL FEATURE. 10 CATHETERS IMPACTED OVER THE LAST FEW WEEKS. PATIENT IS NOT IMPACTED AS STAFF, PINCH OFF THE CATHETER TO MINIMIZE BLOOD LOSS TO PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15140905 ↗
• MalfunctionJun 16, 2022Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE BD CATHENA¿ SAFETY IV CATHETER WITH BD MULTIGUARD¿ SAFETY SHIELD FAILING TO COVER THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER ADVANCING THE CATHETER, THE HCP REMOVED THE NEEDLE; HOWEVER, THE NEEDLE WAS DISENGAGED WITH THE SAFETY SHIELD FAILING TO COVER THE NEEDLE, WHICH WAS LEFT EXPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14713311 ↗
• MalfunctionMar 1, 2022Retraction Problem; Retraction Problem

  IT WAS REPORTED WHILE USING BD CATHENA SAFETY IV CATHETER BD MULTIGUARD TECHNOLOGY 22 GA 1.00 IN A NEEDLE WOULD NOT RETRACT WITH THE SAFETY MECHANISM. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE CUSTOMER'S REPORT, AFTER VENIPUNCTURE, THE HCP ATTEMPTED TO RETRACT THE NEEDLE BUT THE SAFETY MECHANISM WAS NOT ACTIVATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13638868 ↗
• MalfunctionFeb 2, 2022Retraction Problem; Retraction Problem

  IT WAS REPORTED WHEN USING THE BD CATHENA¿ SAFETY IV CATHETER WITH BD MULTIGUARD¿ TECHNOLOGY THE SAFETY MECHANISM WOULD NOT ACTIVATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "AFTER VENIPUNCTURE FOR THE PATIENT, THE HCP ATTEMPTED TO ACTIVATE THE SAFETY MECHANISM TO RETRACT THE NEEDLE; HOWEVER, IT DIDN¿T WORK AND THE NEEDLE WAS EXPOSED." THERE WERE NO REPORTS OF INJURY OR MEDICAL INTERVENTIONS AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13425512 ↗