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

Model Number	RS23SH28
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that approximately six years and four months post dialysis catheter placement, the catheter was allegedly found to be broken.Reportedly, the catheter was removed and replaced with a new catheter.There was no reported patient injury.
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 05/2019).Section a through f: the information provide 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.Device pending return.
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: one bard retro l/t hemodialysis catheter was returned for evaluation.Gross visual, microscopic, tactile and functional testing were performed.A complete diagonal break was noted on the distal end of the catheter.The edges were noted to be uneven, and the surface was noted to be granular.The distal catheter segment was not returned.Therefore, the investigation is confirmed for the reported fracture and the identified material separation issues.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.H10: d4 (expiry date: 05/2019), g3, h6 (device).H11: h6 (method, result, conclusion).H11: section a through f: the information provide 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 approximately six years and four months post dialysis catheter placement, the catheter was allegedly found to be broken.Reportedly, the catheter was removed and replaced with a new catheter.There was no reported patient injury.

• Brand Name: RETRO CATHETER
• Common Device Name: DIALYSIS CATHETERS
• 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: 16928698
• Report Number: 3006260740-2023-01876
• Device Sequence Number: 6878816
• Product Code: MSD
• UDI-Device Identifier: 00801741014062
• UDI-Public: (01)00801741014062
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K203575
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2023

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 Model Number: RS23SH28
• Device Catalogue Number: RS23SH28
• Device Lot Number: ASZL0002
• 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: 04/17/2023
• Supplement Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2016
• 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