MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO 5FR 55 CM DL FT 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

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	02/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Bd vascular access devices field assurance received a sheath for evaluation that had a split at the tip.No other information was provided by the customer.
Additional Manufacturer Narrative
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.
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 an introducer not penetrating the skin without breaking is confirmed and was determined to be manufacturing related.Three 5.0 fr microintroducers were returned for evaluation.An initial visual observation showed blood use residues on all three of the returned devices.Sample one had a kink towards the distal end of the gray sheath, sample two had two kinks along the gray microintroducer sheath, and sample three had a slight bend throughout the entire device.A microscopic observation revealed sample one to have a longitudinally aligned split on the distal end of the gray sheath that appears to be manufacturing related.Samples two and three had no splits in the gray sheaths and no obvious deformation to the distal ends of the devices.Samples two and three had smooth transitions from the distal end of the gray sheath to the introducer.Based on the observations made for each microintroducer, only sample one was related to a manufacturing defect.The complaint of an introducer not penetrating the skin without breaking is confirmed and was determined to be manufacturing related.The investigation was forwarded to the manufacturing facility for further evaluation, and bd is working closely with the manufacturing facility to prevent recurrence of the reported event.
Event or Problem Description
Bd vascular access devices field assurance received a sheath for evaluation that had a split at the tip.No other information was provided by the customer.

• Brand Name: POWERPICC SOLO 5FR 55 CM DL FT 3CG
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16766087
• Report Number: 3006260740-2023-01408
• Device Sequence Number: 6151624
• Product Code: LJS
• UDI-Device Identifier: 00801741223938
• UDI-Public: (01)00801741223938
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2023

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: 01/31/2024
• Device Model Number: N/A
• Device Catalogue Number: CK001028
• Device Lot Number: REGW2650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2023
• Supplement Date Received by Manufacturer: 10/13/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• 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