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

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	12/16/2025
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 manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported that the catheter was noted to be leaking from the red lumen and the team identified a hole in the catheter.Picc exchange was performed.
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 leaking catheter is confirmed; however, the exact cause could not be determined.One 4fr powerpicc sv catheter was returned for evaluation.An initial visual observation revealed the catheter was returned in two segments: the proximal one containing the extension legs and the 7 cm depth mark, and the distal extending from the 8cm to the 24 cm depth mark.A clear dressing and a statlock device were attached to the molded joint, and significant biological residue was present on the sample.A functional test of flushing both lumens of the catheter with water using a 12 ml syringe was performed.A leak was observed just distal to the luer adaptor when flushing the red lumen.No leaks were observed from the white lumen.A microscopic observation revealed a split in the tubing just distal to the red luer adaptor.The surface of the split was observed to have striation-like patterns and radiating tear marks.The edges of the split appeared to be somewhat even.The investigation findings are indicative of flexural fatigue-based failures, which may have been a contributing factor to the extension tubing damage.Repetitive mechanical stresses such as twisting and kinking may have contributed to the observed event; however, it appeared that additional unidentified factors may have contributed.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC SV (SMALL VEINS), 3CG
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• 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: yolanda thompson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 23958392
• Report Number: 3006260740-2025-10195
• Device Sequence Number: 5626207
• Product Code: LJS
• UDI-Device Identifier: 00801741087110
• UDI-Public: (01)00801741087110(11)250904(17)261031(10)REKU1951
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K102159
• 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): 02/24/2026

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 Model Number: N/A
• Device Catalogue Number: 1274108D
• Device Lot Number: REKU1951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2025
• 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