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

Catalog Number	1174108D6
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	03/17/2026
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 date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported via medsun that a single-lumen picc line in an outpatient today that ruptured at the 8 cm mark during a ct scan with contrast.It infiltrated 2 scans worth of contrast into the patient's arm.The line was placed by the picc team.The patient arrived in the ct department for a ct scan with and without contrast.The patient presented with a power picc that had been in place for about two months.I flushed the picc without difficulty, connected the contrast injector, and administered the contrast bolus.After completing the diagnostic scan, i observed that no contrast was visible in the patient¿s vessels or heart on imaging.A bedside assessment showed the picc appeared externally intact, with no visible contrast leakage on the table or floor.I obtained an ap chest scout image, which clearly demonstrated that the contrast bolus had extravasated into the patient¿s arm, confirming picc failure.I notified nursing and radiology.Ice and elevation were applied, and the patient was instructed on signs and symptoms of contrast extravasation.Dr.Assessed the patient and recommended removing the picc to ensure the entire catheter was intact.Rn contacted the provider and obtained a verbal order to discontinue the picc.Rn removed the line and confirmed that the full length of the picc was retrieved from the patient¿s vasculature.I then placed a 20-gauge peripheral iv in the patient¿s left wrist, and both the ct and mri exams were completed without additional issues.The patient was discharged home.

• 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: veronica lee ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 24790012
• Report Number: 3006260740-2026-02309
• Device Sequence Number: 10012420
• 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: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K210264
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/20/2026

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 Catalogue Number: 1174108D6
• Device Lot Number: REJY2716
• 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: 03/17/2026
• Initial Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 50 YR
• Patient Sex: Male