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

Catalog Number	CK000631B
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2026
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.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 device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported, picc leaking the day after insertion.Nurse found that the line was fractured.Additional information received 23-jan-2026: the impact to the patient was an unnecessary line removal and replacement within 12 hours of the original insertion.Normal saline was infusing.
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 leaking catheter is unconfirmed because the problem could not be reproduced.One 4 fr s/l powerpicc catheter was returned for evaluation.An initial visual observation of the returned catheter showed use residues along the device.A functional test of infusing water through the catheter using a 12 ml luer-lock syringe revealed no obvious leaking throughout the catheter.A functional test of pressurizing the catheter with water using a 12 ml luer-lock syringe revealed no leaking throughout the catheter.A functional test of pressurizing the catheter with water using a 12 ml slip-fit syringe revealed the catheter did not exhibit any signs of leakage.A microscopic observation of the catheter showed no splits throughout the returned catheter shaft.No evidence of a leak or other damage was observed on the returned catheter; therefore, the complaint of a leak could not be confirmed.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
Additional information received 23-jan-2026 : when the picc was flushed with normal saline it was painful to the patient and leaking was noted.The fracture was inside the patient.It was secured with a statlock the catheter had to be replaced so the patient could have their treatment.

• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 24221728
• Report Number: 3006260740-2026-00340
• Device Sequence Number: 9293374
• Product Code: LJS
• UDI-Device Identifier: 00801741143748
• UDI-Public: (01)00801741143748(11)251008(17)270131(10)REKW0440
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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 Catalogue Number: CK000631B
• Device Lot Number: REKW0440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2025
• 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