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

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	11/27/2025
Type of Reportable Event	Malfunction
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 device has not been received by the manufacturer for evaluation.Each event reported to bd is evaluated and investigated in accordance with our complaint investigation procedures.The investigation process includes, but is not limited to, evaluation of the event details provided by the complaint facility, a review of complaint history, manufacturing records and risk document where applicable, and an evaluation of the subject device when available to identify potential contributing factors.
Event or Problem Description
It was reported hole/tear in body of picc catheter near 10cm marker, "burst" open while in a patient.Leaking at insertion site was noticed.Line was placed on (b)(6) 2025, starting on (b)(6) 2025 red lumen gave no blood return and this was also reported (b)(6).Red lumen would flush but not have blood return.Other lumens flushed and gave blood return fine.Nurse noticed clear fluid leaking around insertion site on (b)(6) as well and reported to picc team.Picc was dc'd.Swelling and leaking of the insertion site.On ultrasound this vessel was noted as partially non-compressible post catheter removal, with no evidence of thrombosis.Beyond the ultrasound and the series of events reported there are no other details known to our team.
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 leaking catheter is confirmed and was determined to be use-related.One 5 fr t/l powerpicc catheter was returned for evaluation.An initial visual observation revealed a longitudinally aligned split just proximal to the 9 cm depth mark.Ballooning of the catheter between the 11 cm and 12 cm depth marks were also observed, and biological residue was noted on the catheter.A functional test of flushing each lumen of the catheter with water using a 12 ml syringe was performed.A leak was observed just proximal to the 9 cm depth mark when flushing the red lumen, and an occlusion was noted in the lumen as no water was seen flushing through the distal end of the catheter.No leaks or occlusions were observed on the white and gray lumens.A microscopic observation revealed the split appeared to be slightly curved and had smooth and flat fracture surface with clean and straight edges.A circumferential cut was made on the catheter distal to the ballooning section, and a white crystal-like material was seen within the red lumen of the catheter, which was observed to be the cause of the occlusion.The damage observed in the returned sample suggest the catheter experienced over-pressurization (burst) damage due to catheter occlusion.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC
• 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 sparks ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 24251890
• Report Number: 3006260740-2026-00441
• Device Sequence Number: 18556158
• Product Code: LJS
• UDI-Device Identifier: 00801741212802
• UDI-Public: (01)00801741212802(11)250731(17)260731(10)REKT1439
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2026

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: 07/31/2026
• Device Model Number: N/A
• Device Catalogue Number: CK000588B
• Device Lot Number: REKT1439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2025
• 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