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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that the picc line was leakage.Caller contacted medical information with questions regarding how to schedule her medication doses.Caller reported that her picc line was evaluated in the er the previous night due to leakage.Caller stated that, as a result, her medication schedule has been disrupted, and she is seeking guidance on how to resume treatment.Advised the caller to contact her prescribing provider, home infusion pharmacy, or home health nurse for guidance on adjusting her medication schedule.Also advised the caller to have her picc line evaluated, as she reported visiting the er the previous night due to a leaking picc line.During that visit, an additional piece was added to the picc line.The caller stated that she was unable to flush the picc line today.The caller reported that a home health nurse was enroute to her residence to assess the picc line and provide assistance.Additional information received 02sep2026; followed up with hcp, went to oncologist fri (b)(6)2026 before the leakage and scheduled for bloodwork.Pt went to er on (b)(6) for the leakage and er rn replaced tubing that was leaking and added extender.Then the scheduled rn came to do the blood work the next day at her home where the final dose was administered.
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.

• 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: yolanda thompson ; 605 north 5600 west; salt lake city 84116 ; +1(801)595-0700
• MDR Report Key: 50773782
• Report Number: 3006260740-2026-06710
• Device Sequence Number: 18509540
• Product Code: LJS
• UDI-Device Identifier: 00801741155031
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/03/2026

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: S1173108D4
• Device Lot Number: REKY1689
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/21/2026
• 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