MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSTAR DIALYSIS CATHETER

Model Number	5883730
Medical Device Problem Codes	Kinked (1339); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or no medical images have been made available to the manufacturer.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.The investigation of the reported event is currently underway.The information provided by bard 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 bard.
Event or Problem Description
It was reported that a dialysis catheter had allegedly kinked and would not allow flow.There were no other complications.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: dhr was reviewed and no deviations/issues were identified associated with this problem in regards to product materials or during packaging, manufacturing or qc inspection processes.All necessary inspections were performed throughout all the manufacturing, packaging and inspection activities and for raw material utilized in the manufacture of this lot, in regards the problem described.The lot met all release criteria.Labeling review: a review of the product instructions for use (ifu) procedural instructions, indications, warnings, precautions, cautions, possible complications and contraindications showed that the product labeling is adequate.Investigation summary: the device returned was one d/l hemostar xk vas-cath 23cm catheter with surecuff complete.Examination and functional testing of the sample were performed and a permanently deformed section was found on each of the extension legs which is consistent with deformation due to clamping, therefore the investigation is confirmed for (b)(6) - catheter kink.The definitive root cause could not be determined based upon available information.It is unknown if procedural issues contributed to the reported event.
Event or Problem Description
It was reported that a dialysis catheter had allegedly kinked and would not allow flow.There were no other complications.There was no reported patient injury.

• Brand Name: HEMOSTAR DIALYSIS CATHETER
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7589880
• Report Number: 3006260740-2018-01328
• Device Sequence Number: 19369106
• Product Code: MSD
• UDI-Device Identifier: 00801741013607
• UDI-Public: (01)00801741013607
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K051748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2018

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: 5883730
• Device Catalogue Number: 5883730
• Device Lot Number: REBV1228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Initial Date Received by Manufacturer: 05/15/2018
• Supplement Date Received by Manufacturer: 10/05/2018
• Initial Report FDA Received Date: 06/11/2018
• Supplement Report FDA Received Date: 10/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 107