MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC HF (HIGH FLOW), 3CG; PERIPHERALLY INSERTED CENTRAL CATHETER

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	07/10/2025
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 will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported by customer that the assessment of picc line found that one of the lines on a three lumen picc was leaking around the securement device.Flushed all three line, 2 lines worked great.White line was found to be leaking.Once line was pulled.Evaluated the line more in detail and found a split down the side of the picc where the securement device, split was about 1 cm.There was not patient injury.
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 split in the catheter is confirmed and was determined to be use-related.One 5 fr t/l powerpicc catheter was returned for evaluation.An initial visual observation of the returned catheter showed blood residues throughout the device.The catheter was returned with a disassembled secur-a-cath device.Compression damage was observed along the catheter shaft just distal of the molded suture wing to the 2 cm depth marker.A longitudinal split was observed between the 0 cm and 1 cm depth markers.A functional test of attempting to infuse water into each of the lumens using a 12 ml syringe revealed the white lumen to leak while the red and gray lumens were patent to infusion.A microscopic observation of longitudinal split revealed sharp fracture edges and a granular fracture surface.The split was observed to extend longer on the outside surface of the catheter shaft than on the inside surface of the catheter shaft.Use of compression stylet securement devices is likely to have contributed to the failure of the device.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC HF (HIGH FLOW), 3CG
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• 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 ; 8015950700
• MDR Report Key: 22701793
• Report Number: 3006260740-2025-05537
• Device Sequence Number: 8944810
• Product Code: LJS
• UDI-Device Identifier: 00801741085710
• UDI-Public: (01)00801741085710(11)240906(17)260131(10)REJU3499
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• 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): 09/02/2025

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 Expiration Date: 01/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 1385118Q
• Device Lot Number: REJU3499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Supplement Date Received by Manufacturer: 09/01/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2024
• 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 Sex: Unknown