BD Insyte 381237Recalls & reported problems
Becton, Dickinson And Company · INSYTE PNK 20GA X 1.88IN · Class 2
Quick summary
This BD Insyte peripheral IV catheter is a short-term vascular catheter placed into a vein or artery. The 45 adverse event reports mostly describe contamination on the product, leaking at the connection point, and catheters breaking or separating, sometimes leaving a piece inside the patient's artery and causing bleeding. There are 5 injuries and no deaths. Reports rose from 4 in the previous 12 months to 9 in the most recent 12 months. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 44
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00382903812370), received between Feb 4, 2019 and Jan 7, 2026 — classified as 5 injuries, 39 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (12 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material12
- Contamination7
- Leak/Splash7
- Break5
- Defective Component2
- Delivered as Unsterile Product2
- Material Deformation2
- Material Puncture/Hole2
Patient problems
- No Clinical Signs, Symptoms or Conditions33
- Foreign Body In Patient4
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient2
- Aspiration/Inhalation1
- Insufficient Information1
- No Patient Involvement1
- Scar Tissue1
Recent adverse event reports
The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 7, 2026Leak/Splash
IT WAS REPORTED THAT BD INSYTE PNK 20GA X 1.88IN LEAKED ENTRY DESCRIPTION OF (B)(6): ON (B)(6) 2025, A NURSE DISCOVERED LEAKAGE AT THE CONNECTION POINT AFTER PRIMING A SYRINGE. APPROXIMATELY FIVE SYRINGES OF THIS MODEL WERE FOUND TO BE DEFECTIVE IN THE BOX. DURING USE OF THIS PRODUCT, LOOSE CONNECTIONS CAUSED LEAKAGE; ONE UNIT AFFECTED; SAMPLE CAN BE RETURNED WITH PHOTOS PROVIDED; REQUIRES GREEN CLAIMS PROCESSING; REQUIRES COMPLAINT RESPONSE LETTER; REQUIRES COMPLAINT RECEIPT LETTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23999509 ↗MalfunctionDec 10, 2025Break; Break
IT WAS REPORTED THAT BD INSYTE PNK 20GA X 1.88IN CATHETER BROKE / SEPARATED AFTER PLACEMENT IT WAS REPORTED BY THE CUSTOMER THAT WHEN THE CATHETER WAS REMOVED, PART OF THE DEVICE REMAINED IN THE PATIENT'S ARTERY. ACCORDING TO THE NURSE, THE SITE WAS INTACT, AND THE PARAMETERS WERE NORMAL BEFORE THE REMOVAL. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. DATE: 25/11/2025, AS PER CLIENT, WHEN THE CATHETER WAS REMOVED, PART OF THE DEVICE REMAINED IN THE PATIENT'S ARTERY. ACCORDING TO THE NURSE, THE SITE WAS INTACT AND THE PARAMETERS WERE NORMAL BEFORE THE REMOVAL. THERE WAS NO INDICATION OF A POTENTIAL PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23768645 ↗MalfunctionDec 10, 2025Break; Break
IT WAS REPORTED THAT BD INSYTE PNK 20GA X 1.88IN CATHETER BROKE / SEPARATED AFTER PLACEMENT IT WAS REPORTED BY THE CUSTOMER THAT WHEN THE CATHETER WAS REMOVED, PART OF THE DEVICE REMAINED IN THE PATIENT'S ARTERY. ACCORDING TO THE NURSE, THE SITE WAS INTACT, AND THE PARAMETERS WERE NORMAL BEFORE THE REMOVAL. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. DATE: (B)(6) 2025 AS PER CLIENT, WHEN THE CATHETER WAS REMOVED, PART OF THE DEVICE REMAINED IN THE PATIENT'S ARTERY. ACCORDING TO THE NURSE, THE SITE WAS INTACT AND THE PARAMETERS WERE NORMAL BEFORE THE REMOVAL. THERE WAS NO INDICATION OF A POTENTIAL PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23768636 ↗MalfunctionDec 4, 2025Leak/Splash; Material Separation; Leak/Splash; Material Separation
IT WAS REPORTED THAT BD INSYTE PNK 20GA X 1.88IN CATHETER BROKE / SEPARATED AFTER IT WAS REPORTED BY CUSTOMER THAT THE CATHETER WAS BROKEN. DURING THE WITHDRAWAL OF THE CATHETER, PART OF THE DEVICE REMAINED IN THE PATIENT¿S ARTERY. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. WE BOUGHT THE CATHETER IV INSYTE (PINK) 20G X 1.88" RADIOPAQUE ¿ 381237 FROM MEDLINE CANADA. TODAY, (B)(6) 2025, AN INCIDENT OCCURRED IN THE RECOVERY ROOM REGARDING AN INSYTE 20G BD 381237 CATHETER THAT HAD BEEN INSERTED INTO THE OPERATING ROOM EARLIER IN THE DAY. DURING THE WITHDRAWAL OF THE CATHETER, PART OF THE DEVICE REMAINED IN THE PATIENT¿S ARTERY. ACCORDING TO THE NURSE, THE SITE WAS INTACT AND THE PARAMETERS WERE NORMAL BEFORE THE REMOVAL. NOTHING INDICATED A POTENTIAL PROBLEM. AT THE TIME OF WITHDRAWAL, THERE WAS NO RESISTANCE. THE NURSE NOTICED THAT THE CATHETER ALREADY APPEARED TO BE PARTIALLY "OUT" WHEN SHE SIMPLY PEELED OFF THE DRESSING. SIGNIFICANT BLEEDING WAS IMMEDIATELY NOTED. CONSEQUENCES FOR THE PATIENT: ADDITIONAL BLEEDING OCCURRED, AS IT WAS AN ARTERY AND THE NURSE DID NOT IMMEDIATELY NOTICE THAT THE CATHETER WAS BROKEN. FORTUNATELY, NO OTHER COMPLICATIONS WERE OBSERVED, AS THE BROKEN FRA
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23717298 ↗MalfunctionDec 4, 2025Leak/Splash; Material Separation; Leak/Splash; Material Separation
IT WAS REPORTED THAT BD INSYTE PNK 20GA X 1.88IN CATHETER BROKE/SEPARATED AFTER IT WAS REPORTED BY CUSTOMER THAT THE CATHETER WAS BROKEN. DURING THE WITHDRAWAL OF THE CATHETER, PART OF THE DEVICE REMAINED IN THE PATIENT¿S ARTERY. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. WE BOUGHT THE CATHETER IV INSYTE (PINK) 20G X 1.88" RADIOPAQUE ¿ 381237 FROM MEDLINE CANADA. TODAY, (B)(6) 2025, AN INCIDENT OCCURRED IN THE RECOVERY ROOM REGARDING AN INSYTE 20G BD 381237 CATHETER THAT HAD BEEN INSERTED INTO THE OPERATING ROOM EARLIER IN THE DAY. DURING THE WITHDRAWAL OF THE CATHETER, PART OF THE DEVICE REMAINED IN THE PATIENT¿S ARTERY. ACCORDING TO THE NURSE, THE SITE WAS INTACT AND THE PARAMETERS WERE NORMAL BEFORE THE REMOVAL. NOTHING INDICATED A POTENTIAL PROBLEM. AT THE TIME OF WITHDRAWAL, THERE WAS NO RESISTANCE. THE NURSE NOTICED THAT THE CATHETER ALREADY APPEARED TO BE PARTIALLY "OUT" WHEN SHE SIMPLY PEELED OFF THE DRESSING. SIGNIFICANT BLEEDING WAS IMMEDIATELY NOTED. CONSEQUENCES FOR THE PATIENT: ADDITIONAL BLEEDING OCCURRED, AS IT WAS AN ARTERY AND THE NURSE DID NOT IMMEDIATELY NOTICE THAT THE CATHETER WAS BROKEN. FORTUNATELY, NO OTHER COMPLICATIONS WERE OBSERVED, AS THE BROKEN FRAGM
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23717145 ↗MalfunctionDec 2, 2025Break; Break
IT WAS REPORTED THAT BD INSYTE PNK 20GA X 1.88IN CATHETER WAS DEFECTIVE /DAMAGED. IT WAS REPORTED BY THE CUSTOMER THAT AT THE TIME OF REMOVAL, THERE WAS NO RESISTANCE. THE NURSE NOTICED THAT THE CATHETER ALREADY SEEMED PARTIALLY "OUT" WHEN SHE SIMPLY LIFTED THE DRESSING. SIGNIFICANT BLEEDING OCCURRED IMMEDIATELY. CONSEQUENCES FOR THE PATIENT: ADDITIONAL BLEEDING OCCURRED, SINCE IT WAS AN ARTERY AND THE NURSE DID NOT IMMEDIATELY REALIZE THAT THE CATHETER WAS BROKEN. FORTUNATELY, NO OTHER COMPLICATIONS WERE OBSERVED, AS THE BROKEN FRAGMENT COULD BE REMOVED QUICKLY VERBATIM: TODAY, NOVEMBER 21, 2025, AN INCIDENT OCCURRED IN THE RECOVERY ROOM INVOLVING AN INSYTE 20G BD 381237 CATHETER THAT HAD BEEN INSERTED IN THE OPERATING ROOM EARLIER IN THE DAY. DURING THE REMOVAL OF THE CATHETER, A PART OF THE DEVICE REMAINED IN THE PATIENT'S ARTERY. ACCORDING TO THE NURSE, THE SITE WAS INTACT AND THE VITAL SIGNS WERE NORMAL BEFORE REMOVAL. THERE WAS NOTHING TO INDICATE A POTENTIAL PROBLEM. AT THE TIME OF REMOVAL, THERE WAS NO RESISTANCE. THE NURSE NOTICED THAT THE CATHETER ALREADY SEEMED PARTIALLY "OUT" WHEN SHE SIMPLY LIFTED THE DRESSING. SIGNIFICANT BLEEDING OCCURRED IMMEDIATELY. CONSEQUENCES FO
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23696244 ↗MalfunctionDec 2, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT BD INSYTE PNK 20GA X 1.88IN LEAKED. IT WAS REPORTED BY THE CUSTOMER THAT AT THE TIME OF REMOVAL, THERE WAS NO RESISTANCE. THE NURSE NOTICED THAT THE CATHETER ALREADY SEEMED PARTIALLY "OUT" WHEN SHE SIMPLY LIFTED THE DRESSING. SIGNIFICANT BLEEDING OCCURRED IMMEDIATELY. CONSEQUENCES FOR THE PATIENT: ADDITIONAL BLEEDING OCCURRED, SINCE IT WAS AN ARTERY AND THE NURSE DID NOT IMMEDIATELY REALIZE THAT THE CATHETER WAS BROKEN. FORTUNATELY, NO OTHER COMPLICATIONS WERE OBSERVED, AS THE BROKEN FRAGMENT COULD BE REMOVED QUICKLY VERBATIM: TODAY, (B)(6) 2025, AN INCIDENT OCCURRED IN THE RECOVERY ROOM INVOLVING AN INSYTE 20G BD 381237 CATHETER THAT HAD BEEN INSERTED IN THE OPERATING ROOM EARLIER IN THE DAY. DURING THE REMOVAL OF THE CATHETER, A PART OF THE DEVICE REMAINED IN THE PATIENT'S ARTERY. ACCORDING TO THE NURSE, THE SITE WAS INTACT AND THE VITAL SIGNS WERE NORMAL BEFORE REMOVAL. THERE WAS NOTHING TO INDICATE A POTENTIAL PROBLEM. AT THE TIME OF REMOVAL, THERE WAS NO RESISTANCE. THE NURSE NOTICED THAT THE CATHETER ALREADY SEEMED PARTIALLY "OUT" WHEN SHE SIMPLY LIFTED THE DRESSING. SIGNIFICANT BLEEDING OCCURRED IMMEDIATELY. CONSEQUENCES FOR THE PATIENT: ADDITIONAL BLEED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23696237 ↗MalfunctionNov 10, 2025Nonstandard Device; Nonstandard Device
IT WAS REPORTED BY CUSTOMER THAT THE CATHETERS ARE BURRING WHEN TRYING TO PLACE IN PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23509460 ↗InjuryJun 30, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT BD INSYTE PNK 20GA X 1.88IN CATHETER BROKE / SEPARATED AFTER PLACEMENT CANNULA WAS USED FOR ARTERIAL LINE , UPON REMOVING THE CANULA IT HAD BROKEN 1-2MM FROM THE HUB , CANNULA REMAINED IN THE RADIAL ARTERY. ARTERIAL LINE INSERTION ON FIRST PASS, NO WIRE. MONITORED THROUGHOUT PROCEDURE, NOT USED IN PACU
Patient problems: Foreign Body In Patient
MAUDE report 22359955 ↗MalfunctionJan 21, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21200250 ↗MalfunctionJan 21, 2025Contamination; Contamination
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21200247 ↗MalfunctionJan 3, 2025Contamination; Contamination
IT WAS REPORTED THAT BD INSYTE PNK 20GA X 1.88IN HAD FOREIGN MATTER. CLEAR FOREIGN MATERIAL AT THE TIP OF THE NEEDLE WHEN OPENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21072173 ↗MalfunctionSep 24, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT BD INSYTE PNK 20GA X 1.88IN FOREIGN MATTER PRE-USE INSPECTION REVEALS AN UNKNOWN CONTAMINANT AT THE TIP OF THE CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20292804 ↗MalfunctionSep 13, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
THE CUSTOMER OF THE HOSPITAL OPERATING THEATRE OPENED THE OUTER PACKAGING OF THE PRODUCT IN THE MORNING OF 8.19, AND AFTER REMOVING THE PROTECTIVE CAP, HE FOUND THAT THERE WAS DENSE BLACK DIRT ON THE NEEDLE TIP HOSE (THE ACTUAL RECOVERED SAMPLE HAD ALREADY BEEN PARTIALLY WIPED OFF BY THE CUSTOMER'S TEST), AND ON 8.21, THE REMAINING 600 PCS. OF THE BATCH OF THE PRODUCT IN THE HOSPITAL WERE REPLACED ACCORDING TO THE REQUEST OF THE EQUIPMENT SECTION. THE HEAD NURSE WAS OUT FOR A MEETING ON THE SAME DAY AND AGREED TO RETRIEVE THE SAMPLE ON 8.27. THE HOSPITAL REQUESTED A NOTE AND STAMP FROM THE PRODUCT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20212451 ↗MalfunctionSep 3, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT BD INSYTE PNK 20GA X 1.88IN HAD FOREIGN MATTER IT'S ABNORMAL FEELING WHILE USING IT. IT MAY BE SOME FOREIGN MATERIAL INSIDE THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20128754 ↗MalfunctionAug 22, 2024Contamination; Contamination
INSYTE INDWELLING NEEDLE (381237) WAS FOUND TO BE PUSHING OUT CLEAR LUMPY SOLIDS FROM THE CATHETER ON PRE-USE INSPECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20032656 ↗MalfunctionAug 22, 2024Contamination; Contamination
INSYTE INDWELLING NEEDLE (381237) WAS FOUND TO BE PUSHING OUT CLEAR LUMPY SOLIDS FROM THE CATHETER ON PRE-USE INSPECTION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20030989 ↗MalfunctionAug 13, 2024Leak/Splash; Leak/Splash
THE HOSPITALIZED PATIENT 10-10 TO DO ENHANCED CT.THE NURSE IN ACCORDANCE WITH THE ROUTINE OPERATION CONNECTED TO THE INDWELLING NEEDLE HIGH-PRESSURE SYRINGE, INDWELLING NEEDLE TUBING WITHOUT PRESSURE, TWISTING AND SO ON, OPEN THE LOCKING BUCKLE OF THE INDWELLING NEEDLE, TO 3.0ML / S SPEED INJECTION OF SALINE 20M RUSHING TUBE, THE PATIENT IN ADDITION TO A SENSE OF COOL RUSHING FEELING, DID NOT COMPLAIN OF PAIN AND OTHER DISCOMFORTS. THE NURSE OBSERVED THAT THERE WAS NO LOCALIZED LEAKAGE AT THE PUNCTURE SITE, BUT OBSERVED THE ENHANCEMENT OF THE MACHINE DISPLAY, AND THE FLUSHING CURVE WAS NOT SMOOTH. SO AGAIN TO 3.0M / S SPEED INJECTION OF SALINE 20ML TO, RUSHING TUBE PROCESS FOUND THAT THE INDWELLING NEEDLE HEPARIN CAP END OF THE PIPELINE RUPTURE LIQUID OUTFLOW AND A SLIGHT SENSE OF WRINKLES, IMMEDIATELY STOP THE OPERATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19974159 ↗MalfunctionAug 12, 2024Contamination; Contamination
INSYTE INDWELLING NEEDLE (381237) WAS FOUND TO BE PUSHING OUT CLEAR LUMPY SOLIDS FROM THE CATHETER ON PRE-USE INSPECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19963855 ↗MalfunctionAug 6, 2024Contamination; Contamination
INSYTE INDWELLING NEEDLE (381237) WAS FOUND TO HAVE A BLACK UNIDENTIFIED SUBSTANCE IN THE CATHETER IN SEVERAL PLACES DURING PRE-USE INSPECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19922171 ↗MalfunctionAug 5, 2024Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT BD INSYTE PNK 20GA X 1.88IN NEEDLE THROUGH CATHETER WHILE INTRODUCING CATHETER AFTER PUNCTURING THE BLOOD VESSEL, ADVANCING THE INFUSION TUBE IS MORE DIFFICULT THAN BEFORE. THIS NOW ALSO OFTEN CAUSES MORE PAIN TO THE PATIENT. THE INFUSIONIST FEELS THAT THE CURRENT INFUSION TUBES ARE STIFFER THAN BEFORE, AND THAT MORE RESISTANCE CAN ALSO BE FELT WHEN SLIDING AND INSERTING THE INFUSION. THE INFUSION NEEDLES FROM THE PREVIOUS BATCH NO. 2328939 DID NOT GIVE THESE PROBLEMS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19909659 ↗MalfunctionAug 2, 2024Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent
INSYTE INDWELLING NEEDLES (381237) WERE FOUND TO HAVE A ROUGH TIP AND SILICONE OIL LUMPS WERE PUSHED OUT OF THE CATHETER ON PRE-USE INSPECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19893170 ↗MalfunctionJun 18, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion
CUSTOMER SAYS THAT THE ARTICLE IS UNUSABLE AS THE CATHETER BREAKS UPON USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19557790 ↗MalfunctionMay 29, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
THE CUSTOMER REPORTED THAT THERE WAS A JELLY-LIKE VISCOUS UNKNOWN SUBSTANCE IN THE INDWELLING NEEDLE AND ASKED THE COMPANY TO INSPECT IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19420765 ↗MalfunctionDec 15, 2023Leak/Splash; Leak/Splash
LEAKAGE AT THE INTERFACE BETWEEN THE INDWELLING NEEDLE AND THE INFUSION SKIN STRIP WAS NOTED DURING USE.
Patient problems: Insufficient Information
MAUDE report 18340565 ↗
Other Catheter,intravascular,therapeutic,short-term less than 30 days devices
- BD Insyte Autoguard 382523Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days660 reports
- BD Insyte Autoguard 382533Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls527 reports
- BD PosiFlush 306546Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 death608 reports
- BD Insyte Autoguard Shielded IV Catheter 381823Becton, Dickinson And Company · Catheter, intravascular, therapeutic, short-term less than 30 days582 reports
- BD Insyte Autoguard 381423Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall528 reports
- BD Insyte Autoguard 382544Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall437 reports
- BD Nexiva, BD Q-Syte 383536Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls374 reports
- BD PosiFlush 306547Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls1 death331 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.