MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SV (SMALL VEINS); 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	02/08/2025
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.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 via medwatch, "iv team called to assess picc line.White lumen found with crack where portion of white leg meets white portion that needleless connector attaches to.This leg of the picc (peripherally inserted central catheter) was clamped and betadine gauze was wrapped around the break.Md aware and advised to consult ir (interventional radiology) to coordinate with pt's already scheduled operating room procedure tomorrow." additional information received 3/24/2025: it was reported line last rewired new on (b)(6) 2025: catheter type: 4 fr, 2 lumen catheter, 19 cm in length, picc line, power injectable.Break identified on (b)(6) 2025.Dressing applied: occlusive dressing applied, picc sutured to skin to avoid accidental dislodgment.The line is sutured with 0.5 cm external length, and a 3m chg occlusive dressing was applied over the site.The line was rewired.
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.

• Brand Name: POWERPICC SV (SMALL VEINS)
• 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21693255
• Report Number: 3006260740-2025-01735
• Device Sequence Number: 9419435
• Product Code: LJS
• UDI-Device Identifier: 00801741027864
• UDI-Public: (01)00801741027864(11)240920(17)271130(10)REJU1306
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K102159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2025

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 Model Number: N/A
• Device Catalogue Number: 3274355
• Device Lot Number: REJU1306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 04/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2024
• 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: 24 MO
• Patient Sex: Male