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

Model Number	N/A
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that they have a defective picc that we were hoping to get replaced.The taper started at the 6cm mark, so it would not advance into the sheath past that point.
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.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.The complaint of a thick catheter is confirmed and was determined to be manufacturing related.One 3 fr powerpicc solo catheter was returned for evaluation.An initial visual observation revealed the catheter started to taper distal to the 5 cm depth marking.A side-by-side comparison was made using a non-complainant 3 fr powerpicc catheter and the returned catheter was observed to be thicker than the non-complainant catheter.A microscopic observation revealed the texture of the outer surface of the catheter appeared to be somewhat rough.The outer diameter of the returned catheter was measured distal to the molded joint and distal to the 5 cm depth marking and was found to be about 0.06767in.And 0.06631 in., respectively.A non-complainant catheter was also measured distal to the 5 cm depth marking and was found to be 0.04600in., which indicates the returned catheter was significantly thicker than the non-complaint catheter in that section.As per drawing, the outer diameter of the catheter distal to the tapered region should be 0.0465 ± 0.0005in.This indicates outer diameter of the returned catheter is above specification.This investigation has been forwarded to the manufacturing site, and awareness training has been performed with the manufacturing operators regarding this complaint.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC PROVENA
• 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: chelsea raehl ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 23931578
• Report Number: 3006260740-2025-10111
• Device Sequence Number: 13168429
• Product Code: LJS
• UDI-Device Identifier: 00801741154980
• UDI-Public: (01)00801741154980(11)250531(17)260630(10)REKR1224
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/29/2025

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: 06/30/2026
• Device Model Number: N/A
• Device Catalogue Number: S1193108D3
• Device Lot Number: REKR1224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2025
• 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