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

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a picc insertion procedure, after successfully advancing the guidewire, the dilator intended for advancing the picc guidewire was found to be defective and could not perform dilation.As a result, the physician discarded the defective dilator and proceeded with a new picc kit to complete the procedure.No patient impact.
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 dilator is inconclusive due to the state of the returned sample.Three photographs of a powerpicc catheter kit were returned for evaluation.Observation of the returned photographs showed various powerpicc catheter components in an opened kit tray.No obvious use residues were observed along the devices in the returned photographs.A dilator was not observed in the returned photographs.Inspection of the returned photograph was insufficient to identify the alleged issue or a root cause of the reported issue.Therefore, this complaint is inconclusive at this time.This complaint will be recorded for future trending and monitoring purposes.
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 dilator is inconclusive due to the state of the returned sample.Three photographs of a powerpicc catheter kit and an open powerpicc kit were returned for evaluation.An initial visual observation of the returned sample revealed all of the components of the kit were present except for the microintroducer.No obvious use residue was observed on the returned components of the kit.Observation of the returned photographs showed various powerpicc catheter components in an opened kit tray.No obvious use residues were observed on the devices in the returned photographs.A microintroducer was not observed in the returned photographs.Inspection of the returned photographs and physical sample was insufficient to confirm the alleged issue or identify a root cause of the reported issue.Therefore, this complaint is inconclusive at this time.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: 24182593
• Report Number: 3006260740-2026-00190
• Device Sequence Number: 10177689
• Product Code: LJS
• UDI-Device Identifier: 00801741027932
• UDI-Public: (01)00801741027932(11)250330(17)260930(10)REKN3703
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K051991
• 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,Followup
• Report Date (Section B): 04/03/2026

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: 09/30/2026
• Device Model Number: N/A
• Device Catalogue Number: 3275155
• Device Lot Number: REKN3703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2026
• Supplement Date Received by Manufacturer: 03/13/2026; 04/03/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 03/17/2026; 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2025
• 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