MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA; 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	08/18/2025
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 it will be evaluated.A supplemental report will be submitted with evaluation results.
Event or Problem Description
It was reported that picc had issues with the peel away micro introducer "splintering" while the nurse was attempting to insert.We opened a new kit and used the introducer from the new kit without issue.
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 microintroducer is confirmed; however, the exact cause could not be determined.One 4.5 fr microintroducer was returned for evaluation.An initial visual observation revealed use residue on the sample.The microintroducer shaft was observed to be bent and the sheath tip was observed to be damaged.A microscopic observation revealed a split, buckling, and plastic deformation at the sheath tip.Biological residue was observed between the sheath and the dilator.The tip of the dilator was unremarkable.While the exact cause of the observed damage could not be determined, possible contributing factors include a steep insertion angle, inadequate skin nick, and/or forceful insertion against resistance.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC PROVENA
• 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: kelly m. rackley ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 22995132
• Report Number: 3006260740-2025-06699
• Device Sequence Number: 13034020
• Product Code: LJS
• UDI-Device Identifier: 00801741155055
• UDI-Public: (01)00801741155055(11)250225(17)260228(10)REKN2016
• Combination Product (Y/N): Y
• Initial Reporter State: OK
• 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,Followup
• Report Date (Section B): 10/07/2025

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: 02/28/2026
• Device Model Number: N/A
• Device Catalogue Number: S1274108D4
• Device Lot Number: REKN2016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 10/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2025
• 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