MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 4F SL MAX BARRIER PLUS KIT W/GUARDIVA; 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	04/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer "a picc was leaking when flushed.After assessment from our nurse, she was not able to fix the issue so she pulled this line.Once the line was pulled she noted a "slit" at approximately just past the 10cm section of the line.The line was place by our staff approximately 6 weeks prior to the issue and had been receiving outpatient iv home therapy" additional information received 4/9/2024: it was reported by the customer "patient had picc placed without incident per our company with 3cg confirmation.Unsure of the events that took place at home if they [patient] used excessive force etc.To push meds or flush.She replaced the line in the opposite arm.No long lasting complications noted to the patient.".
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.
Event or Problem Description
It was reported by the customer "a picc was leaking when flushed.After assessment from our nurse, she was not able to fix the issue so she pulled this line.Once the line was pulled she noted a "slit" at approximately just past the 10cm section of the line.The line was place by our staff approximately 6 weeks prior to the issue and had been receiving outpatient iv home therapy".Additional information received 4/9/2024: it was reported by the customer "patient had picc placed without incident per our company with 3cg confirmation.Unsure of the events that took place at home if they [patient] used excessive force etc.To push meds or flush.She replaced the line in the opposite arm.No long lasting complications noted to the patient.".
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 4fr sl powerpicc catheter.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 a split was observed between the 4cm and 5cm depth markers.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.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.

• Brand Name: POWERPICC 4F SL MAX BARRIER PLUS KIT W/GUARDIVA
• 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19235015
• Report Number: 3006260740-2024-02045
• Device Sequence Number: 12485671
• Product Code: LJS
• UDI-Device Identifier: 00801741154935
• UDI-Public: (01)00801741154935
• 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): 05/16/2024

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: 12/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 1174108D3
• Device Lot Number: REHV2435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2024
• Supplement Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 06/07/2024
• 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