MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SFTCEL-PC RJ 19CM KIT; DIALYSIS CATHETER

Model Number 5534190

Device Problems Loss of or Failure to Bond (1068); Fluid/Blood Leak (1250); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/27/2020

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.

Event Description

It was reported that approximately four years and three months post catheter placement, the catheter allegedly fractured in two pieces.It was further reported that the catheter cuff was allegedly detached.Reportedly, the catheter was removed and another new catheter was replaced.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a lot history review, a dhr review and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: one catheter was returned for evaluation.Functional, gross visual, tactile and microscopic visual evaluations were performed.Two photos were also provided and reviewed.The investigation is confirmed for catheter fracture and external leak, as a small partial fracture was identified at the connection between the bifurcation and catheter shaft.The edges of the fracture were observed to be jagged.Leaking was observed at the partial fracture during in-lab functional testing.The investigation is also confirmed for detached cuff, as the cuff was observed to be detached from the catheter in both the photo review and in the physical sample evaluation.A definitive root cause for the reported failure 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: g4, h6 (device: 1562).H11: h6 (result, conclusion).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 four years and three months post catheter placement, the catheter allegedly fractured in two pieces.It was further reported that the catheter cuff was allegedly detached.Reportedly, the catheter was removed and another new catheter was replaced.There was no reported patient injury.

• Brand Name: SFTCEL-PC RJ 19CM KIT
• Type of Device: DIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10127165
• MDR Text Key: 194306917
• Report Number: 3006260740-2020-01994
• Device Sequence Number: 1
• Product Code: LFJ
• UDI-Device Identifier: 00801741012440
• UDI-Public: (01)00801741012440
• Combination Product (y/n): N
• PMA/PMN Number: K030277
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5534190
• Device Catalogue Number: 5534190
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2020
• Date Manufacturer Received: 09/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1