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

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	12/09/2025
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 during catheter placement on (b)(6) it was discovered that the guidewire inside the mst had uneven thickness and a barbed tip at the front end.After replacing it with a new catheter, the same issue occurred.Another batch was then replaced for catheter placement.This report addresses both faulty devices.
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 guidewire was inconclusive due to the sample condition.A single photograph of a guidewire was returned for evaluation.No apparent kinks or breaks were noted in the guidewire.A red circle had been annotated onto the photograph, indicating the area of concern.The diameter of the guidewire changed in this region.Per the device specifications, the guidewire consists of a full-length tapered core wire with a coil wire wrapped around the distal tip.It appeared that the area circled in the photograph was of the transition where the coil wire was attached.As the physical device was not returned, it could not be determined if the device was outside of the dimensional specifications nor could the device be evaluated for microscopic transition flaws.As the submitted photograph did not contain enough information to confirm the event or identify a specific root cause, this complaint will be recorded as inconclusive.This complaint will be recorded for future trending and monitoring purposes.A sample was not returned for the other reported occurrence; therefore, that occurrence is also inconclusive.

• Brand Name: POWERPICC SOLO
• 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: 23851494
• Report Number: 3006260740-2025-09893
• Device Sequence Number: 9571826
• Product Code: LJS
• UDI-Device Identifier: 00801741218125
• UDI-Public: (01)00801741218125(11)241004(17)260831(10)REJW2028
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K210264
• 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,Followup
• Report Date (Section B): 03/09/2026

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: 08/31/2026
• Device Model Number: N/A
• Device Catalogue Number: C1295118
• Device Lot Number: REJW2028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2024
• 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