MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER, POLYURETHANE, KIT, 14.5F

Model Number 5703690

Device Problems Fluid/Blood Leak (1250); Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/15/2023

Event Type  malfunction  

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 not been returned to the manufacturer for evaluation.However, photos and a video were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 02/2024) h11: section a through f - the information provided by bd represents all of 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 Description

It was reported that approximately less than two months post dialysis catheter placement, blood exudation allegedly occurred from the catheter body during routine dialysis.It was further reported that the catheter body had allegedly cracked.The procedure was completed using another device.There was no reported patient injury.

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.Two electronic photos and one video were reviewed.Both photographs showed a patient with a clinician holding a swab at or near the catheter, near the catheter exit site.There was a small amount of blood in the area immediately surrounding the exit site.In the video the clinician is still holding the swab, and repeatedly touches it to the catheter just below the exit site while pushing the catheter inward (into the patient) somewhat, so that it bends slightly.No source of bleeding or leak was apparent.No damage to the catheter was apparent.Therefore, based on the photo and video review, the reported catheter crack and leakage cannot be confirmed.A definitive root cause for the reported cracking and blood exudation could not be determined based upon the provided 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: (expiry date: 02/2024).H11: section a through f - the information provided by bd represents all of 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.H3 other text: device not returned.

Event Description

It was reported that approximately less than two months post dialysis catheter placement, blood exudation allegedly occurred from the catheter body during routine dialysis.It was further reported that the catheter body had allegedly cracked.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER, POLYURETHANE, KIT, 14.5F
• Type of Device: 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: 17369514
• MDR Text Key: 319677676
• Report Number: 3006260740-2023-03099
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741012884
• UDI-Public: (01)00801741012884
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K030020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/15/2023

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
• Device Operator: Health Professional
• Device Model Number: 5703690
• Device Catalogue Number: 5703690
• Device Lot Number: REGQ2661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2023
• Initial Date FDA Received: 07/21/2023
• Supplement Dates Manufacturer Received: 09/15/2023
• Supplement Dates FDA Received: 09/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1