MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSTAR HEMODIALYSIS CATHETER

Model Number 5833690

Device Problems Difficult to Remove (1528); Device Dislodged or Dislocated (2923); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/03/2020

Event Type  malfunction  

Manufacturer Narrative

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 19cm hemostar d/l catheter was returned for evaluation.Visual, microscopic, and tactual tests were performed.The investigation is confirmed for a sheath stuck to catheter, as the microscopic and tactile observations appear to show the sheath on the catheter.Furthermore, the investigation is confirmed for dislodgement as the microscopic and tactile observations appear to show that the sheath is left on the catheter when it should have been on the tunneler.Although there is splitting on the damaged sheath segment it is uncertain if this is related to the procedure or post procedure.Although a definitive root cause could not be determined, excessive friction between components, incompatible dimensions, or tool damage could have potentially caused or contributed to the reported event.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.(expiry date: 05/2021).

Event Description

It was reported that during dialysis catheter placement, the white site of the tunneler component was allegedly stuck on the catheter and could not be removed.There was no reported patient injury.

• Brand Name: HEMOSTAR HEMODIALYSIS CATHETER
• Type of Device: DIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd montebello #1; parque industrial colonial; reynosa tamaulipas 88780 ; MX 88780
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 10186768
• MDR Text Key: 197355607
• Report Number: 3006260740-2020-02187
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741013386
• UDI-Public: (01)00801741013386
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K051748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5833690
• Device Catalogue Number: 5833690
• Device Lot Number: REDU1608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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