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

Model Number	N/A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Deformation (2976)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, patient with a line issue that the patient had placed on (b)(6) it was a single lumen for at home therapy.The patient states that he was discharged home without issues.Within a couple weeks he was having issues with infusions flowing so he was seen at the infusion clinic.The nurse did some interventions and got the line working again and on the morning of (b)(6), patient woke up around 0100 with some tenderness to the arm and cold to touch, the patient and his family also states that the line was leaking at the site.He then went to the emergency department to be evaluated where the team was eventually notified and sent a vast nurse on the morning of (b)(6).Upon assessment the patient had a visible kink in the upper arm area upon x-ray the line was pulled and noted to have a pin size whole and number marks have worn off.The line was removed.The patient had another picc placed and no harm was noted.
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 damaged catheter was confirmed.The product returned for evaluation was one 4fr single lumen powerpicc solo catheter.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 4cm and 5cm 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.The damage location suggested that catheter securement, access and maintenance techniques may have contributed.

• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 22531130
• Report Number: 3006260740-2025-04929
• Device Sequence Number: 15458104
• Product Code: LJS
• UDI-Device Identifier: 00801741143748
• UDI-Public: (01)00801741143748(11)241112(17)260131(10)REJX0309
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2025

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: 01/31/2026
• Device Model Number: N/A
• Device Catalogue Number: CK000631B
• Device Lot Number: REJX0309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2024
• 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