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

Model Number	5733690
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that fourteen days post dialysis catheter placement, the catheter was allegedly fractured.It was further reported that blood was leaking from the ruptured part.Reportedly, the device was removed and replaced.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 is currently being performed.The device has been returned to the manufacturer for evaluation.However, a photo and videos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 05/2024).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 fourteen days post dialysis catheter placement, the catheter was allegedly fractured.It was further reported that blood was leaking from the ruptured part.Reportedly, the device 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: one 19cm hemosplit d/l catheter was returned for evaluation.In addition to the returned sample, one electronic photo and two electronic videos were provided for review.The photo shows one hemosplit catheter implanted in a patient and a split was noted on the red luer extension leg.The videos shows the catheter implanted in the patient body and a split was noted on the red luer.Gross, microscopic visual and functional testing were performed.Two longitudinal splits, in-parallel, were observed on the red luer extension leg and upon infusion of the red luer, leaking was noted from the parallel splits on the extension leg.Aspiration of water into the syringe was attempted but was unsuccessful; only air was aspirated.Therefore, the investigation is confirmed for the reported fracture and fluid leak issues.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiration date: 05/2024).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.

• Brand Name: HEMOSPLIT CATHETER
• 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: 16974417
• Report Number: 3006260740-2023-02031
• Device Sequence Number: 2317446
• Product Code: MSD
• UDI-Device Identifier: 00801741013096
• UDI-Public: (01)00801741013096
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K030020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 07/13/2023

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 Model Number: 5733690
• Device Catalogue Number: 5733690
• Device Lot Number: REGW0180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2023
• Supplement Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 05/22/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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