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

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that few introducers that have been really difficult to introduce, causing us to open a whole new kit.Additional information received 19-may-2026: the insertions were not difficult until the picc nurse got to the introducer part.At that point, upon introduction there was some difficulty and then a lip that developed making it impossible to continue even with further dermatotomy.This resulted in another kit having to be opened.No further details provided.06/30/2026 it was found during investigation that revealed a bend on the microintroducer shaft and damage at the sheath tip.
Additional Manufacturer Narrative
The complaint of a damaged microintroducer is confirmed and was determined to be use-related.One 5 fr microintroducer was returned for evaluation.An initial visual observation revealed a bend on the microintroducer shaft and damage at the sheath tip.A microscopic observation revealed buckling and plastic deformation at the tip of the sheath, and biological residue was observed between the dilator and the sheath.The observed damage can occur due to a steep insertion angle, inadequate skin nick, and/or forceful insertion against resistance.The product ifu states, "advance the microintroducer assembly over the guidewire.Using a twisting motion, advance the assembly into the vessel.If necessary, a small incision may be made adjacent to the guidewire to facilitate insertion of the sheath and dilator." 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: yolanda thompson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 25815342
• Report Number: 3006260740-2026-04939
• Device Sequence Number: 10602219
• Product Code: LJS
• UDI-Device Identifier: 00801741034558
• UDI-Public: (01)00801741034558(11)251014(17)270131(10)REKW0913
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• 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): 07/03/2026

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: 1275108D
• Device Lot Number: REKW0913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 07/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2025
• 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