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

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	06/13/2025
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 date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The failure was found during evaluation of a returned sample.Additional investigation is required to determine the cause of the failure.Results of the investigation are expected soon.
Event or Problem Description
It was reported that sealed lot sample returned with confirmed split sheath tip.
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 microintroducer is confirmed and was determined to be manufacturing related.Twenty-four 5 fr triple lumen powerpicc provena kits were returned for evaluation.An initial visual observation revealed 23 of the powerpicc provena kits were returned sealed and the microintroducer in these kits appeared unremarkable.A microscopic observation of the 23 returned samples revealed the following: 18 microintroducers were unremarkable, and no defect could be confirmed.4 microintroducers appeared to have an abrupt transition; however, an evaluation completed by the manufacturing facility revealed the transition between sheath and dilator are acceptable according to the specifications in the vs5001684.Therefore, no defect could be confirmed for these samples.1 microintroducer was observed to have a split sheath tip with some material webbing within.These findings suggest the potential cause for the observed defect is related to manufacturing.Photographs of this sample were sent to the manufacturing site for further evaluation.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC PROVENA THICK TAPER, 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: 22396235
• Report Number: 3006260740-2025-04514
• Device Sequence Number: 4901729
• Product Code: LJS
• UDI-Device Identifier: 00801741155024
• UDI-Public: (01)00801741155024(11)241105(17)251231(10)REJW2532
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• 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): 07/16/2025

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: 12/31/2025
• Device Model Number: N/A
• Device Catalogue Number: S1395108D3
• Device Lot Number: REJW2532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2024
• 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