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	02/01/2025
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.The manufacturer has received the sample and it will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported the picc line had fractures.Resulted in unexpected or prolonged care for one patient.
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 leak is confirmed; however, the exact cause is unknown.One 4 fr dual lumen powerpicc sv was returned for evaluation.An initial visual observation showed use residue on the returned sample.A split was observed in the extension leg tubing of the white lumen.The catheter was trimmed just distal to the molded joint.Both lumens of the returned catheter were flushed with a 12 ml syringe of water.Leakage was observed from the split in the extension leg of the white lumen, but no leaks were observed when the red lumen was flushed.A microscopic observation revealed the split in the extension tubing at the distal end of the white luer hub.The fracture surface of the split was observed to be flat but uneven and exhibited cracks/fissures and beach marks, which are suggestive of material fatigue.However, the exact cause of the observed damage in the returned sample is unknown.Possible contributing factors include pulling, twisting, and manipulation of the luer connector hub and/or extension leg.This complaint will be recorded for future trending and monitoring purposes.

• 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: 21882911
• Report Number: 3006260740-2025-02487
• Device Sequence Number: 20799608
• Product Code: LJS
• UDI-Device Identifier: 00801741027857
• UDI-Public: (01)00801741027857
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K102159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2025

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: 3274335
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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