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

Catalog Number	6393190
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260); Material Separation (1562); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that eight months and thirty days post a dialysis catheter placement, the catheter was allegedly ruptured.Furthermore, the physician found that there was allegedly a leak at the connection between the hub and the catheter.Reportedly, the catheter was replaced.There was no reported patient injury.
Additional Manufacturer Narrative
H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.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.
Additional Manufacturer Narrative
H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the glidepath products that are cleared in the us.The pro code and 510 k number for the glidepath products are identified in d2 and g4.H10: as the lot number for the device was provided, a review of the device history records was performed.The device has not been returned to the manufacturer for evaluation.However, photo was provided for review.The investigation of the reported event is currently underway.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 eight months and thirty days post a dialysis catheter placement, the catheter was allegedly ruptured.It was further reported that the physician found that there was allegedly a leak at the connection between the hub and the catheter.Furthermore, kink was also found between the hub and catheter.Reportedly, the catheter was removed and replaced.There was no reported patient injury.
Event or Problem Description
It was reported that eight months and thirty days post a dialysis catheter placement, the catheter was allegedly ruptured.It was further reported that the physician found that there was allegedly a leak at the connection between the hub and the catheter.Furthermore, kink was also found between the hub and catheter.Reportedly, the catheter was removed and replaced.There was no reported patient injury.
Additional Manufacturer Narrative
H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the glidepath products that are cleared in the us.The pro code and 510 k number for the glidepath products are identified in d2 and g4.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: although the physical device was not returned for evaluation, one electronic photo was provided for review.The photo shows an implanted catheter.Therefore, the investigation is inconclusive for the reported fluid leak, kink and fracture issue as the provided photo was unclear and not sufficient enough to confirm the reported events.A definitive root cause could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: g3, h6(method) h11: h6(result, conclusion) 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.
Additional Manufacturer Narrative
H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the glidepath products that are cleared in the us.The pro code and 510 k number for the glidepath products are identified in d2 and g4.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: one 19cm glidepath d/l catheter in three segments were returned for evaluation and one electronic photo was provided for review.Visual, microscopic, tactile and functional evaluations were performed on the returned device.A complete circumferential break was noted to the blue luer extension leg.The edges of the complete circumferential break on the blue luer extension leg were noted to be jagged and the surface was noted to be granular throughout.Therefore, the investigation is confirmed for the reported fluid leak and fracture and the identified material separation issues.However the investigation is inconclusive for the reported kink issue as a part of the blue extension leg segment was not received for evaluation.A definitive root cause could not be determined based upon the provided 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 eight months and thirty days post a dialysis catheter placement, the catheter was allegedly ruptured.It was further reported that the physician found that there was allegedly a leak at the connection between the hub and the catheter.Furthermore, kink was also allegedly found between the hub and catheter.Reportedly, the catheter was removed and replaced.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: 19834322
• Report Number: 3006260740-2024-04062
• Device Sequence Number: 6627658
• Product Code: MSD
• UDI-Device Identifier: 00801741187315
• UDI-Public: (01)00801741187315
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K051748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/04/2024

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: 12/31/2024
• Device Catalogue Number: 6393190
• Device Lot Number: REHP3669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2024
• Supplement Date Received by Manufacturer: 07/29/2024; 08/26/2024; 12/04/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 08/22/2024; 09/17/2024; 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2023
• 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