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

Model Number	N/A
Medical Device Problem Codes	Material Frayed (1262); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported guidewire noted to be difficult to remove and replace in line prior to placement in patient. upon removal, guidewire curled like a ribbon and made the line unusable.Patient's skin was shredded.No further information was provided.
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.
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 damaged stylet was confirmed but the root cause could not be determined.The product returned for evaluation was one 4fr sl powerpicc catheter w/ t-lock assembly and 3cg stylet.A gross visual inspection of the returned unit found that multiple bends were present on the catheter tubing and on the core wire of the stylet.No use residues were observed throughout the unit, but the stylet was returned already partially retracted through the t-lock septum, suggesting that the device had seen some use but had not been inserted into a patient.The t-lock assembly and core wire were decoupled from the catheter.Upon decoupling, the bends in the catheter tubing disappeared, indicating that the bend was only on the stylet.Further inspection of the stylet, after decoupling, found that multiple bends in a wave pattern were present in the stylet core wire across approximately 40 cm of the core wire.The wave pattern had a roughly consistent wave length and height, suggesting that the deformation was caused by a repetitive action from a single source.Microscopic inspection of the returned unit found shearing of the catheter tubing between the 10 cm and 38 cm depth markers.The long stretches of damage in both the catheter tubing and core wire potentially suggested that the damage to the components may have occurred after the stylet had been coupled with the catheter.A similar non-complainant unit was taken and manipulated to attempt to replicate the wave like pattern observed in the returned unit.However, none of the testing conducted was able to replicate the pattern.Based on the available material for review, the complaint is confirmed but there is insufficient evidence to identify the root cause.This complaint will be recorded for future trending and monitoring purposes.

• 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: becky sparks ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 23646606
• Report Number: 3006260740-2025-09031
• Device Sequence Number: 4823730
• Product Code: LJS
• UDI-Device Identifier: 00801741034459
• UDI-Public: (01)00801741034459(11)250606(17)260630(10)REKR1218
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2026

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: 06/30/2026
• Device Model Number: N/A
• Device Catalogue Number: 1174108D
• Device Lot Number: REKR1218
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2025
• 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 Sex: Unknown