MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC; 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	12/01/2025
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 will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported that picc line split along side of line causing 2 of the 3 lumen to malfunction and spray liquid out the side.Line was secured with secure-a-cath during placement and split occurred inside this area of line.No patient harm.
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 leaking catheter is confirmed and was determined to be related to use of the device alongside a compression style device.One 5 fr t/l powerpicc catheter was returned for evaluation.An initial visual observation revealed blood residues along the device.A split was observed along the catheter shaft between the 0 cm and 1 cm depth markers.A second split was observed from between the 0 cm and 1 cm depth markers to the 2 cm depth marker.The splits were observed to be opposite each other.A functional test of attempting to infuse water into each of the three lumens using a 12 ml syringe revealed the gray and red lumens leaked while the white lumen was patent to infusion.A functional test of attempting to infuse water distal of each of the two splits using a 12 ml syringe and a proximal groshong connector piece revealed the gray lumen and the red lumen to be occluded with blood residues.A microscopic observation revealed the smaller split observed between the 0 cm and 1 cm depth marker to have more of an ¿s¿ shape, and its fracture surface appeared granular with sharp fracture edges.The larger split from between the 0 cm and 2 cm depth markers was observed to have more of a ¿c¿ shaped curve with a granular fracture surface and sharp fracture edges.Microscopic observations of each split revealed characteristics of damage caused by the use of a compression-style securement device such as a secur-a-cath device.The ifu states ¿warning: the potential of developing a crimp/fold/crease in the catheter that progresses to leak and catheter burst may increase with the use of securement systems which compress the catheter tubing, specifically in the taper region of the catheter.¿ this complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC
• 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: 23842496
• Report Number: 3006260740-2025-09828
• Device Sequence Number: 9835311
• 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: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2026

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: 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: 12/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2025
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 02/19/2026
• 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