BioFlo 45891Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI H965458910), received between Aug 10, 2016 and May 15, 2026 — classified as 58 malfunctions.

The most frequently reported specific device problem is “Crack” (50 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2026Crack

  AN END USER REPORTED AN ISSUE WHEN USING THE BIOFLO 4F SL 55CM MST-70 KIT VALVED WITH NITINOL GUIDEWIRE PG. THE HUB WAS OBSERVED TO BE CRACKED ALONG THE LUER THREADS. TREATMENT WAS DELAYED AND THE AFFECTED DEVICE HAD TO BE REMOVED AND REPLACED WITH A DIFFERENT PRODUCT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25191984 ↗
• MalfunctionDec 5, 2025Material Deformation; Material Deformation

  SPECTRUM REPORTED AN END USER EXPERIENCED AN ISSUE BIO-STABLE 4F SL 55CM MST-70 KIT VALVED WITH NITINOL GUIDEWIRE. IT WAS REPORTED THAT OVER SEVERAL DAYS AFTER THE PATIENT'S PICC WAS PLACED, WHEN THE PATIENT WAS ATTACHED TO CONTINUOUS INFUSION, THE PATIENT'S LOWER ARM SWELLS. WITH BASIC MANUAL FLUSH OF 10-20ML OF SALINE THE SWELLING IS NOT NOTED. IT ONLY OCCURS DURING THE CONTINUOUS INFUSION. AN X-RAY WAS PERFORMED ON THE ARM AND CHEST. THE TIP OF THE CATHETER WAS IN THE SVC, HOWEVER, THERE WAS A KINK OBSERVED APPROXIMATELY 5-6CM ABOVE THE INSERTION SITE. THE PICC WAS REMOVED AND REPLACED. UPON REMOVAL, A CURVE IN THE PICC WAS NOTED AT THE 4-6CM MARK.

  Patient problems: Swelling/ Edema

  MAUDE report 23728733 ↗
• MalfunctionSep 17, 2025Crack; Crack

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A BIO-STABLE 4F SL 55CM MST-70 KIT VALVED WITH NITINOL GUIDEWIRE. THE PATIENT HAD RECEIVED ABOUT HALF OF THE PRESCRIBED TREATMENT, ABOUT 300 ML IN 30 MINUTES, WHEN THE CYTOSTATIC (HUB) BEGAN TO LEAK. THE CRACK ON THE OUTSIDE IS ONLY VISIBLE WHEN THE DEVICE IS TURNED ON, AND IT OPENS UP A LITTLE. THE CRACK IS MINIMAL, BUT UNFORTUNATELY SUFFICIENT FOR LEAKAGE. THE CATHETER WAS INSERTED ((B)(6) 2025) AND REMOVED ((B)(6) 2025).IT WAS REPORTED THE PICC LINE WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23074320 ↗
• MalfunctionSep 9, 2025Crack; Crack

  A DISTRIBUTOR REPORTED THAT AN END USER EXPERIENCED AN ISSUE WHEN USING A BIO-STABLE 4F SL 55CM MST-70 KIT VALVED WITH NITINOL GUIDEWIRE. IT WAS REPORTED THAT A PATIENT PRESENTED TO THE EMERGENCY ROOM DUE TO A LEAKING PICC-LINE THAT WAS DISCOVERED DURING FLUSHING OF THE DEVICE. A CRACK WAS DISCOVERED IN THE OUTER, PURPLE PART OF THE DEVICE. THE PATIENT RECEIVED A NEW PICC-LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23004778 ↗
• MalfunctionAug 4, 2025Crack; Crack

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WITH A BIO-STABLE 4F SL 55CM MST-70 KIT VALVED WITH NITINOL GUIDEWIRE. IT WAS REPORTED THE PICC HAD A CRACKED HUB. DUE TO THE CRACK, THE PICC WAS REMOVED. THE PATIENT FINISHED TREATMENT PERIPHERALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22700996 ↗
• MalfunctionJul 1, 2025Crack; Crack

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A BIO-STABLE 4F SL 55CM MST-70 KIT VALVED WITH NITINOL GUIDEWIRE. IT WAS REPORTED THAT A PATIENT'S PICC THAT WAS PLACED (B)(6) 2025 WAS DISCOVERED ON (B)(6) 2025 TO HAVE A CRACKED HUB. THE PICC WAS REMOVED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22371685 ↗
• MalfunctionJul 1, 2025Crack; Crack

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A BIO-STABLE 4F SL 55CM MST-70 KIT VALVED WITH NITINOL GUIDEWIRE. IT WAS REPORTED THAT A PATIENT'S PICC THAT WAS PLACED (B)(6) 2025 WAS DISCOVERED ON (B)(6) 2025, TO HAVE A CRACKED HUB. THE PICC WAS REMOVED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22371680 ↗
• MalfunctionMay 7, 2025Fracture; Fracture

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WITH A PICC FROM A BIO-STABLE 4F SL 55CM MST-70 KIT VALVED WITH NITINOL GUIDEWIRE. THE PATIENT HAD THEIR BIOFLO PICC INSERTED FOR HOME PARENTERAL NUTRITION (PN) ON (B)(6) 2024. AS REPORTED TO MSA, THERE HAS BEEN A "BREAKAGE OF WHITE SECTION OF EXTENSION TUBING" ON A BIOFLO PICC THAT WAS ORIGINALLY IMPLANTED IN (B)(6) 2024, FOR HOME PARENTERAL NUTRITION (PN) PURPOSES. THE "]CRACK' WAS NOTICED BY THE PATIENT'S MOTHER ON (B)(6) 2025, WHEN SHE HAD UNHOOKED THE PN AND SAW A DROP OF BLOOD ON THE SHEET. THE PICC WAS REMOVED THE SAME DAY, (B)(6) 2025. [DWELL TIME: 124 DAYS] THE PATIENT HAS HAD A NEW BIOFLO PICC IMPLANTED ON (B)(6) 2025, TO CONTINUE INTRAVENOUS THERAPY (IVT) AND DAILY BLOOD SAMPLING. WHEN ASKED FOR THE CURRENT STATUS OF THE PATIENT FOLLOWING THE EVENT, THE NURSE RESPONDED: "PRESENTATION TO EMERGENCY DEPARTMENT. PIVC INSERTION (PREVIOUS DIFFICULT AND TRAUMATIC PIVC INSERTIONS SO THE IDEA OF THIS WAS PARTICULARLY DISTRESSING TO THE PATIENT AND FAMILY). NO NUTRITION UNTIL NEW PICC INSERTED (HAD IV FLUIDS TO MAINTAIN HYDRATION)."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21977275 ↗
• MalfunctionDec 5, 2024Crack; Crack

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A PICC FROM A BIO-STABLE 4F SL 55CM MST-70 KIT VALVED WITH NITINOL GUIDEWIRE. THE PATIENT HAD THEIR BIOFLO PICC INSERTED FOR HOME PARENTERAL NUTRITION (PN). APPROXIMATELY 42 DAYS POST PROCEDURE, IT WAS NOTED THE PURPLE HUB OF THE PICC WAS CRACKED AND LEAKING FLUID. THE PICC WAS REMOVED REQUIRING CANNULATION UNDER SEDATION. A NEW PICC WAS INSERTED UNDER GA [GENERAL ANAESTHETIC] A FEW DAYS LATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20853802 ↗
• MalfunctionAug 21, 2024Crack; Crack

  A DISTRIBUTOR REPORTED THE FOLLOWING ISSUE WITH A BIO-STABLE 4F SL 55CM MST-70 KIT VALVED WITH NITINOL GUIDEWIRE PG: ONE OF OUR CUSTOMERS (CLINICAL NURSE, VASCULAR ASSESSMENT AND MANAGEMENT SERVICE) HAS NOTIFIED MSA OF AN INCIDENT INVOLVING A BIOFLO PICC (4FR SINGLE LUMEN 55CM) (REF# 45-891, LOT# 5777081). THE PATIENT (5 YEARS OLD, FEMALE) HAD THEIR BIOFLO PICC INSERTED (B)(6) 2023 FOR HOME PARENTERAL NUTRITION (PN), AND IVABS. [DIAGNOSIS: TTC7A MUTATION] THE ISSUE (CRACKED/FRACTURED CATHETER HUB) WAS FIRST NOTICED WHEN "PN WAS LEAKING INTO BED AT HOME (HOME PN)." CUSTOMER HAS ALSO ADVISED THAT A NEEDLESS CONNECTOR (LUER-LOCK) WAS CONNECTED TO THE HUB AT THE TIME THE ISSUE WAS NOTICED. THE BRAND NAME IS REPORTED TO BE: NANOCLAVE THE PATIENT HAS HAD THEIR PICC REMOVED ((B)(6) 2024) UNDER GENERAL ANAESTHESIA AND HAS HAD A REPLACEMENT DEVICE (BIOFLO PICC: ITEM REF. UNSPECIFIED AND LOT NUMBER UNSPECIFIED) INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20010391 ↗
• MalfunctionMay 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WITH A PICC FROM A BIO-STABLE 4F SL 55CM MST-70 KIT VALVED WITH NITINOL GUIDEWIRE. THE END USER REPORTED THE FOLLOWING:"WE HAD A PATIENT RECENTLY WHOSE PICC LINE WAS PERIODICALLY FILLING WITH BLOOD AND I CONSIDERED IT MAY BE A FAULTY PASV".THE ISSUE WAS FIRST NOTICED BY THE PATIENT'S MOTHER SEVERAL WEEKS AFTER PLACEMENT AFTER THE PATIENT HAD BEEN ASLEEP. IT WAS REPORTED THAT THERE WAS "FREQUENT AND RECURRENT BLOOD FILLING LINE DESPITE CHANGING BUNGS, DRIPPING FROM LINE WHEN BUNG REMOVED TO BE CHANGED". THE CUSTOMER NOTED THAT IT HAD A POSITIVE DISPLACEMENT BUNG [I.E. NEEDLESS CONNECTOR, BD MAX PLUS M1000C-0006] ON IT AND THE BUNG HAD BEEN CHANGED BY MEDICAL PROFESSIONALS (ACCORDING TO THE MOTHER) BUT THE "FILLING" STILL OCCURRED.THE FACILITY/CUSTOMER HAS NOTED MANY OCCURRENCES FOLLOWING THIS INITIAL DETECTION DESPITE CHANGING OF BUNGS AND PULSATILE FLUSHING.THE PICC WAS REMOVED ON THE 19TH MARCH DUE TO "SITE INFECTION".A NEW PICC WAS NOT INSERTED, THE CUSTOMER/HOSPITAL ADVISED: "NO NEW PICC WAS INSERTED AS THE PATIENT HAS A PORT" (UNKNOWN MODEL). ADDITIONAL INFORMATION: IT WAS A EXUDATIVE SITE INFECTION, AND AS SUCH, THE LINE

  Patient problems: Bacterial Infection

  MAUDE report 19258434 ↗
• MalfunctionNov 30, 2023Crack; Crack

  AN END USER REPORTED AN ISSUE WITH A PICC FROM A BIO-STABLE 4F SL 55CM MST-70 KIT; VALVED WITH NITINOL GUIDEWIRE. THEY REPORTED THEY RECENTLY HAD TO REMOVE A PICC LINE FROM A PATIENT THAT WAS RECEIVING CHEMOTHERAPY AS THE HUB OF THE LINE HAD A CRACK IN IT. THE LINE WAS INSERTED (B)(6) 2023 AND REMOVED (B)(6) 2023, SO WAS ROUGHLY IN USE FOR APPROX. 2 MONTHS. DUE TO THE NEED TO REMOVE THE LINE, THE INFUSION TREATMENT WAS DELAYED. THE CRACK WAS NOTICED DURING ROUTINE MAINTENANCE WHEN THE FLUID FLUSH (SALINE) SPRAYED OUT THE SIDE OF THE LUMEN. THE NEEDLESS CONNECTOR AND A LUER LOCK SYRINGE WERE CONNECTED TO THE HUB AT THE TIME. THE NEEDLESS CONNECTOR WAS A BD SMARTSITE NEEDLE-FREE CONNECTOR. A NEW PICC WAS NOT PLACED AS THE PATIENT ELECTED TO STOP THE TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18239726 ↗
• MalfunctionDec 6, 2022Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  FIRST REPORTED INCIDENT FOR THIS PATIENT: A DISTRIBUTOR REPORTED AN ISSUE WITH A BIO-STABLE 4F SL 55CM MST-70 KIT VALVED WITH NITINOL GUIDEWIRE. IT WAS REPORTED THAT THE PATIENT HAS EXPERIENCED TWO HUB CRACKS, WITHIN A PERIOD OF 2 YEARS. THE PATIENT'S NURSE SUSPECTS THAT THE PATIENT'S PARENTS ARE OVERTIGHTENING THE BUNG BUT THIS HAS NOT BEEN CONFIRMED. THE FIRST INCIDENT OF A HUB CRACK FOR THIS PATIENT HAD NOT BEEN PREVIOUSLY REPORTED TO THE DISTRIBUTOR. THE MOST RECENT HUB CRACK WAS DISCOVERED ON (B)(6) 2022 AND THE DEVICE WAS REMOVED AND REPLACED ON THE SAME DAY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AS A RESULT OF THIS ISSUE AND IS REPORTED TO BE HOME AND CONTINUING TO RECEIVE PARENTERAL NUTRITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15924004 ↗
• MalfunctionDec 6, 2022Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  SECOND REPORTED INCIDENT FOR THIS PATIENT: A DISTRIBUTOR REPORTED AN ISSUE WITH A BIO-STABLE 4F SL 55CM MST-70 KIT VALVED WITH NITINOL GUIDEWIRE. IT WAS REPORTED THAT THE PATIENT HAS EXPERIENCED TWO HUB CRACKS, WITHIN A PERIOD OF 2 YEARS. THE PATIENT'S NURSE SUSPECTS THAT THE PATIENT'S PARENTS ARE OVERTIGHTENING THE BUNG BUT THIS HAS NOT BEEN CONFIRMED. THE FIRST INCIDENT OF A HUB CRACK FOR THIS PATIENT HAD NOT BEEN PREVIOUSLY REPORTED TO THE DISTRIBUTOR. THE MOST RECENT HUB CRACK WAS DISCOVERED ON (B)(6) 2022 AND THE DEVICE WAS REMOVED AND REPLACED ON THE SAME DAY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AS A RESULT OF THIS ISSUE AND IS REPORTED TO BE HOME AND CONTINUING TO RECEIVE PARENTERAL NUTRITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15923993 ↗
• MalfunctionJan 3, 2022Backflow; Backflow

  A DISTRIBUTOR REPORTED AN ISSUE WITH A BIO-STABLE 4F SL 55CM MST-70 KIT VALVED WITH NITINOL GUIDEWIRE PG. POST PROCEDURE, IT WAS NOTED THE VALVE WAS NOT FUNCTIONING AS INTENDED AND PRODUCING BLEED BACK. THE DEVICE WAS REMOVED FROM THE PATIENT. IT WAS NOT INDICATED NOR REPORTED THAT THE PICC WAS REPLACED. THERE WAS NO REPORT OF PATIENT HARM OR ADVERSE EVENT BY THE END USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13145890 ↗
• MalfunctionOct 11, 2021Crack; Crack

  A DISTRIBUTOR REPORTED AN ISSUE WITH A BIO-STABLE 4F SL 55CM MST-70 KIT VALVED WITH NITINOL GUIDEWIRE PG. POST PROCEDURE, A CRACK WAS DISCOVERED IN THE HUB, WHEN THE CATHETER WAS FLUSHED BY A HOME CARE PROVIDER. THE DEVICE WAS REMOVED FROM THE PATIENT AND THERE WAS NO REPORT OF PATIENT HARM OR ADVERSE EVENT BY THE END USER. THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12605296 ↗
• MalfunctionAug 31, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  A DISTRIBUTOR REPORTED AN ISSUE WITH A BIO-STABLE 4F SL 55CM MST-70 KIT VALVED WITH NITINOL GUIDEWIRE. THE FOLLOWING WAS REPORTED: ON (B)(6) 2021 THE PICC WAS SUCCESSFULLY PLACED. LATER THAT SAME DAY, THE PATIENT RECEIVED CXR TO CONFIRM THE TIP LOCATION. IT WAS NOTED THE PICC TIP HAD CROSSED TO THE LEFT SUBCLAVIAN BY APPROXIMATELY 7CM. THE PICC WAS PULLED BACK BY 7.5CM AND IT WAS DETERMINED IT WAS OKAY TO CONTINUE USING. ON (B)(6) 2021, DURING IVC (R) HAND, THE PICC SITE WAS DRESSED WITH CREPE BANDAGE. IT WAS NOTED STRIKE THROUGH BLEEDING. THE MEDICAL PERSONNEL COVERED THE SITE AND WAS NOT CONCERNED. THE PICC WAS ABLE TO BE ACCESSED STILL. IVABX WAS ADMINISTERED AS CHARTED. IT WAS ALSO NOTED THE PATIENT'S LEFT FOOT WAS SHOWING OEDEMA, REDNESS. THE PATIENT STATED IT WAS NOT CAUSING ANY PAIN OR ISSUES. ON (B)(6) 2021, THE PATIENT REPORTED TO NURSE THAT HE WAS BLEEDING. THE NURSE REPORTED: "I LOOKED AT THE PICC, NOTICED THE BUNG HAD BEEN REMOVED AND IT WAS BLEEDING. I PUT A BUNG ON THE PICC AND CLEANED THE PATIENT UP". THE NURSE INFORMED THEIR TEAM LEADER AND MEDICAL TEAM AND THE PICC WAS REMOVED LATER THAT SAME DAY (B)(6) AS PER THE MEDICAL TEAM'S INSTRUCTION. THE PICC WAS DISCARDED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12392007 ↗
• MalfunctionJul 1, 2021Difficult to Flush; Difficult to Flush

  A DISTRIBUTOR REPORTED AN ISSUE WITH A BIO-STABLE 4F SL 55CM MST-70 KIT VALVED WITH NITINOL GUIDEWIRE. DURING A PROCEDURE, THE VALVE APPEARED TO BE NON-FUNCTIONING. THE END USER ATTEMPTED TO FLUSH REPEATEDLY TO SEE IF THAT WOULD ACTIVATE THE VALVE; HOWEVER, THIS WAS UNSUCCESSFUL. VERY HIGH VENOUS PRESSURE WAS SUSPECTED AND DUE TO A TECHNICALLY DIFFICULT PROCEDURE AND POOR PATIENT STATUS, THE DECISION WAS MADE TO LEAVE THE CATHETER IMPLANTED FOR A FEW DAYS. IT IS UNKNOWN IF THE PICC WAS REPLACED. THERE WAS NO REPORT OF THE PATIENT EXPERIENCING ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. IT WAS INDICATED THAT THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12102051 ↗
• MalfunctionMar 7, 2021Crack; Crack

  AN END USER REPORTED AN ISSUE WITH A BIO-STABLE 4F SL 55CM MST-70 KIT. POST PROCEDURE, A CRACK WAS DISCOVERED IN THE HUB OF THE CATHETER. THE PICC WAS BEING USED FOR TREATMENT WITH ANTIBIOTICS AND KABIVEN. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER CATHETER. THERE WAS NO REPORT OF PATIENT HARM OR ADVERSE EVENT AS A RESULT OF THIS INCIDENT. IT WAS INDICATED THAT THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11429671 ↗
• MalfunctionJan 17, 2021Crack; Crack

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WITH A BIOFLO PICC WITH PASV. WHEN ACCESSING THE PICC FOR TREATMENT, IT WAS NOTED THE THE HUB WAS CRACKED. THE PICC WAS BEING USED FOR TPN AND CHEMOTHERAPY. THE CATHETER WAS REMOVED IN THE NURSING HOME AND THE PATIENT PRESENTED TO THE REPORTING FACILITY FOR A NEW PICC PLACEMENT. THE PICC WAS REPLACED WITH A NEW OF THE SAME, AND THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THIS EVENT. THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11182948 ↗
• MalfunctionDec 20, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  A DISTRIBUTOR REPORTED AND END USER EXPERIENCED AN ISSUE WITH A BIOSTABLE PICC WITH PASV AFTER INDWELL. THE PICC HAD BEEN PLACED IN THE PATIENT'S ARM, AND WAS BEING USED FOR ANTIBIOTICS, TPN AND CHEMOTHERAPY. THE PATIENT CALLED FROM HOME TO REPORT TO THEIR PROVIDER THAT THE HUB HAD CRACKED. IT WAS REPORTED THE PICC WAS REMOVED BY ANOTHER PROVIDER AND NOT THE HOSPITAL THAT REPORTED THIS COMPLAINT, THEREFORE THE DEVICE IS NOT AVAILABLE FOR RETURN. IT WAS NOT REPORTED IF THE PICC WAS REPLACED, HOWEVER, IT IS REASONABLE TO CONCLUDE THE PICC WAS REPLACED IN ORDER TO CONTINUE TREATMENT. THE REPLACEMENT DEVICE TYPE IS UNKNOWN. THE PATIENT WAS REPORTED AS UNAFFECTED BY THIS EVENT. IT WAS INDICATED THAT THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11043108 ↗
• MalfunctionDec 10, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  A DISTRIBUTOR REPORTED AN ISSUE WITH A BIOSTABLE 4F PICC W/PASV. THE PICC WAS DISCOVERED TO HAVE A CRACK IN THE VALVE BODY (HUB). THE DEVICE WAS REMOVED AND REPLACED AND THERE WAS NO REPORT OF PATIENT HARM OR ADVERSE EVENT BY THE END USER. IT WAS INDICATED THAT THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10983339 ↗
• MalfunctionNov 29, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  A DISTRIBUTOR REPORTED AN ISSUE WITH A BIOSTABLE 4F PICC W/PASV. THE PICC WAS DISCOVERED TO HAVE A CRACK IN THE VALVE BODY (HUB). THE DEVICE WAS REMOVED, AND IT IS REASONABLE TO CONCLUDE THE DEVICE WAS REPLACE IN ORDER TO CONTINUE TREATMENT OF TPN AND CHEMOTHERAPY. THERE WAS NO REPORT OF PATIENT HARM OR ADVERSE EVENT BY THE END USER. IT WAS INDICATED THAT THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10916276 ↗
• MalfunctionNov 10, 2020Crack; Crack

  A DISTRIBUTOR REPORTED AN ISSUE WITH A BIOSTABLE 4F PICC W/PASV. THE PICC WAS DISCOVERED TO HAVE A CRACK IN THE VALVE BODY (HUB). THERE WAS NO REPORT OF PATIENT HARM OR ADVERSE EVENT BY THE END USER. IT WAS INDICATED THE REPORTED DEVICE IS AVAILABLE FOR RETURN TO THE MANUFATURER FOR A DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10816048 ↗
• MalfunctionOct 12, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  A DISTRIBUTOR REPORTED THAT A PATIENT'S BIOSTABLE PICC WAS FOUND TO BE CRACKED AT THE HUB AFTER LEAKAGE WAS OBSERVED. THE PATIENT'S PICC WAS REMOVED AND REPLACED WITH A NEW CATHETER. THERE WAS NO PATIENT HARM OR INJURY DUE TO THIS EVENT. IT WAS INDICATED THAT THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10667154 ↗