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

Catalog Number	5835230
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that nine months and thirteen days post a dialysis catheter placement, there was a tear in the arterial part of the catheter just at the distal exit of the hub.It was further reported that the tear also caused some air to be drawn into the catheter.Reportedly, the catheter was removed and 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 device has not been returned to the manufacturer for evaluation.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: 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.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.
Event or Problem Description
It was reported that nine months and thirteen days post a dialysis catheter placement, there was a tear in the arterial part of the catheter just at the distal exit of the hub.It was further reported that the tear also caused some air to be drawn into the catheter.Furthermore, it was found that there was allegedly a leak.Reportedly, the catheter was removed and replaced.There was no reported patient injury.
Event or Problem Description
It was reported that nine months and thirteen days post a dialysis catheter placement, there was a tear in the arterial part of the catheter just at the distal exit of the hub.It was further reported that the tear also caused some air to be drawn into the catheter.Furthermore, it was found that there was allegedly a leak.Reportedly, the catheter was removed and replaced.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the sample was not returned for evaluation.Five electronic photos were provided for review.The catheter fracture was noted in the photos.Therefore, the investigation is confirmed for the reported fracture and fluid leak.However, the investigation is inconclusive for the reported air in device issue as provided photos are not sufficient to confirm the issue.A definitive root cause could not be determined based upon the available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: g3.H11: h6 (method, 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.

• Brand Name: HEMOSTAR
• 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: 20381492
• Report Number: 3006260740-2024-05737
• Device Sequence Number: 15455735
• Product Code: MSD
• UDI-Device Identifier: 00801741013508
• UDI-Public: (01)00801741013508(17)250228(10)REHQ4690
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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
• Report Date (Section B): 12/20/2024

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: 02/28/2025
• Device Catalogue Number: 5835230
• Device Lot Number: REHQ4690
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 10/07/2024; 12/20/2024
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 11/01/2024; 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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