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

Model Number	N/A
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the introducer not breaking away as anticipated to expose the catheter.Proceeded to cut the introducer with a scalpel to finish procedure.Power flushed the line and inspected the exposed catheter prior to inserting to verify its functionality and visualized no issues with the catheter itself.No patient impact.
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 defective micro introducer sheath is confirmed; the cause was determined to manufacturing related.One photograph of a micro introducer was returned for evaluation.An initial visual observation of the photograph showed two sheath halves of a split micro introducer with a small orange ring of plastic retained on one of the halves; indicating an improper break.No other observations were noted concerning a reasoning behind the improper break.Use residue was noted on the device.The distinguishing features in the returned photograph of the device indicate the root cause of the issue is likely manufacturing related.A capa has been opened to address this issue.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: 23851491
• Report Number: 3006260740-2025-09892
• Device Sequence Number: 21225422
• Product Code: LJS
• UDI-Device Identifier: 00801741232152
• UDI-Public: (01)00801741232152(11)250116(17)260331(10)REJY2716
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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): 02/20/2026

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: 03/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 1174108D6
• Device Lot Number: REJY2716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2025
• 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: 02/20/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2025
• 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