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	Chemical Exposure (2570)
Date of Event	11/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported post cyclophosphamide flush, went to disconnect patient from iv infusion pump, as treatment was completed, however, small amount of orange appearing liquid (doxorubicin) was noted underneath picc dressing, prior to disconnecting lines.Surrounding skin dry to the touch.Outer dressing dry to the touch.Old dressing removed, cleansed skin, flushed lines with ns to check for leaks, no apparent leaks noted.New dressing change & line care completed.Patient went for imaging today and it was noted that there was a pin hole leak in the picc line, no harm to 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 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 leaking catheter is confirmed and was determined to be use-related.One 5fr dual-lumen powerpicc catheter was returned for evaluation.An initial visual observation revealed biological residue on the sample.Both lumens of the sample were flushed with a 12 ml syringe of water, and a leak was observed just distal to the molded joint when the red lumen was flushed.A microscopic observation revealed the split exhibited somewhat round/polished edges, wrinkling of the catheter surface, and a rough fracture surface texture.Whitening of the catheter material was also observed at the corners of the split.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 in the catheter.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: 23704424
• Report Number: 3006260740-2025-09203
• Device Sequence Number: 10595874
• Product Code: LJS
• UDI-Device Identifier: 00801741027925
• UDI-Public: (01)00801741027925(11)250308(17)260930(10)REKP0786
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K051991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2026

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: 09/30/2026
• Device Model Number: N/A
• Device Catalogue Number: 3275135
• Device Lot Number: REKP0786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2025
• 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