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 Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
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 issue with flexibility of picc, after placement in the patient, kinking of the catheter occurred.No harm to patient.It was reported this occurred with 6 devices.This report addresses all 6 devices.
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 bent guidewires is confirmed; however, the exact cause is unknown.One photograph of a powerpicc catheter and one photograph of guidewires were returned for evaluation.An initial visual observation of the photograph of the powerpicc catheter showed a bend in the catheter.Blood use residues were observed in the returned photograph of the powerpicc catheter.The bend appeared to be caused by a guidewire or stylet inside the catheter shaft.The returned photograph of guidewires showed some use residues in the returned photograph.The distal ends of each guidewire appeared bent.No significant kinking was observed along the distal ends of the guidewires in the returned photograph.Because no additional details of the bends in the guidewires could be observed in the returned guidewires, the root cause of the bends could not be determined.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: yolanda thompson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 24269364
• Report Number: 3006260740-2026-00574
• Device Sequence Number: 10021224
• Product Code: LJS
• UDI-Device Identifier: 00801741034657
• UDI-Public: (01)00801741034657(11)250701(17)260731(10)REKS1434
• Combination Product (Y/N): Y
• Initial Reporter Country: SA
• 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): 04/07/2026

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: 07/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 1385108QD
• Device Lot Number: REKS1434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2025
• 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