MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC, 3CG; PERIPHERALLY INSERTED CENTRAL CATHETER (PICC)

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported we had one of our staff called to replace a line that our company had previously inserted 20 days prior due to leaking at the site.When she started troubleshooting and called me we opted to pull the line to inspect.She found it had a large hole at the 4.5 cm mark.History on this patient: he has been in and out of the nursing home and caring for the line himself along with home health.He states it had begun to get sluggish and then started to leak yesterday am.I suspect that someone uses excessive force to flush, however i can not prove that.No injury was noted to the patient.Negative outcome was that the patient had to come in for a replacement picc due to leaking.Unfortunately, due to his extensive history we were not able to get another picc placed at the bedside and the patient was then sent to ir.
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The complaint of a leak was confirmed.The product returned for evaluation was one 4 fr single lumen powerpicc solo.The investigation findings are consistent with damage accumulated through flexural fatigue.Flexural fatigue may occur due to cyclic kinking of the catheter tube in which physiological, placement, usage, and mechanical factors may gradually form a crack(s) in the catheter.The returned product sample was evaluated, and a split was observed between the 4 cm and 5 cm depth markings.The catheter split contained physical features associated with material fatigue, and the characteristics observed which supported this type of failure included: ¿ damage which was circumferentially aligned.¿ fracture edges which were rounded and polished due to repeated material wear.¿ 'c' shaped impressions leading into the fracture site which are consistent with material buckling due to movement which caused the fracture edges to be pressed together.¿ overall elliptical shape to the fracture cross-section (a result of repeated kinking of the tubing).Repetitive kinking of the indwelling catheter appears to have contributed to the observed leak; however, the specific circumstances surrounding how kinking developed into a fracture within the catheter tubing were ultimately unknown.An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC, 3CG
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER (PICC)
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21329045
• Report Number: 3006260740-2025-00430
• Device Sequence Number: 8604058
• Product Code: LJS
• UDI-Device Identifier: 00801741155147
• UDI-Public: (01)00801741155147(11)240823(17)251130(10)REJU1606
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K070996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2025
• Device Model Number: N/A
• Device Catalogue Number: 1174108D5
• Device Lot Number: REJU1606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown