MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO® CATHETER 4F SL 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

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	02/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that outpatient picc came back into hospital due to leaking.They did not see a leak until they removed the picc line and say a hole in the picc about 5cm down.Additional information received 02/26/2024: patient had picc placed (b)(6) 2024 was discharged home.He returned to the hospital (b)(6) 2024 evening due to picc leaking.On (b)(6) 2024, went to evaluate patients picc (b)(6), removed picc and there was a leak.Placed new picc (b)(6) 2024.
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 evaluate.Results are expected soon.
Event or Problem Description
It was reported by the customer that outpatient picc came back into hospital due to leaking.They did not see a leak until they removed the picc line and say a hole in the picc about 5cm down.Additional information received 02/26/2024: patient had picc placed (b)(6) 2024 was discharged home.He returned to the hospital (b)(6) 2024 evening due to picc leaking.On (b)(6) 2024, went to evaluate patients picc (b)(6), removed picc and there was a leak.Placed new picc (b)(6) 2024.
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 is confirmed and was determined to be use related.One 4fr sl powerpicc solo catheter was returned for evaluation.The investigation findings are consistent with damage accumulated through flexural fatigue.Flexural fatigue occurs 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 two splits were observed at the 16cm an 17cm marks on the catheter body.The catheter splits 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 ¿ overall elliptical shape to the fracture cross-section (a result of repeated kinking of the tubing) an examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.The damage location suggested that catheter securement, access and maintenance techniques may have contributed.This complaint will be recorded for future trending and monitoring purposes.H3 other text : evaluation findings are in section h11.

• Brand Name: POWERPICC SOLO® CATHETER 4F SL 3CG
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18908760
• Report Number: 3006260740-2024-01110
• Device Sequence Number: 6188950
• Product Code: LJS
• UDI-Device Identifier: 00801741188091
• UDI-Public: (01)00801741188091
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2024

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: 10/31/2024
• Device Model Number: N/A
• Device Catalogue Number: CK000930
• Device Lot Number: REHV2643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2024
• Supplement Date Received by Manufacturer: 03/18/2024
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 04/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2023
• 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