MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GLIDEPATH; DIALYSIS CATHETER

Catalog Number	5304150
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Fracture (1260); Difficult to Insert (1316); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a dialysis catheter placement procedure, the valve of the peel away introducer was allegedly broken off.It was further reported that the catheter was allegedly difficult to insert through the peel away sheath.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records will be performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiration date: 08/2024).H11: section a through f ¿ the information provided by bd represents all 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.
Event or Problem Description
It was reported that during a dialysis catheter placement procedure, the valve of the peel away introducer was allegedly broken off.It was further reported that the catheter was allegedly difficult to insert through the peel away sheath.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: received one fully peeled 10.0fr peel-apart sheath for evaluation.Visual evaluation was performed.Both valve caps were noted to be detached from the t-handle.Ultrasonic weld material was noted throughout the detached valve caps.According to manufacturing review, a closer view showed that the valve and top caps were detached from the t-handle, it was observed that the valve was not separated, however, it had a longitudinal cut towards one of the edges.Therefore, the investigation is confirmed for the reported loss of or failure to bond and material separation.However, the investigation is inconclusive for the reported difficult to insert issue as the exact circumstance at the time of the event reported event was unknown.The root cause was related to manufacturing.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.The information provided by bd represents all 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.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: received one fully peeled 10.0fr peel-apart sheath for evaluation.Visual evaluation was performed.Both valve caps were noted to be detached from the t-handle.Ultrasonic weld material was noted throughout the detached valve caps.According to manufacturing review, a closer view showed that the valve and top caps were detached from the t-handle, it was observed that the valve was not separated, however, it had a longitudinal cut towards one of the edges.Therefore, the investigation is confirmed for the reported loss of or failure to bond, material separation.However, the investigation is inconclusive for the reported difficult to insert issue as the exact circumstance at the time of the event reported event was unknown.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H11: section a through f ¿ the information provided by bd represents all 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.
Event or Problem Description
It was reported that during a dialysis catheter placement procedure, the valve of the peel away introducer sheath allegedly broke off as an attempt was made to peel it away.It was further reported that the catheter was then allegedly difficult to insert through the peel away sheath, therefore, another device had to be opened and backtrack to complete the procedure.There was no reported patient injury.

• Brand Name: GLIDEPATH
• Common Device Name: DIALYSIS 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18885162
• Report Number: 3006260740-2024-01023
• Device Sequence Number: 2997766
• Product Code: MSD
• UDI-Device Identifier: 00801741187308
• UDI-Public: (01)00801741187308(11)230915(17)240831(10)REHU3239
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K200627
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/03/2024

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: 08/31/2024
• Device Catalogue Number: 5304150
• Device Lot Number: REHU3239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2024
• Supplement Date Received by Manufacturer: 05/21/2024; 12/03/2024
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 05/28/2024; 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2023
• 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
• Patient Sex: Unknown