MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSTAR XK LONG-TERM HEMODIALYSIS CATHETER, POLYURETHANE, 16F; CHRONIC VENOUS CATHETER HEMOSTAR

Model Number	5883730
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 08/2020).
Event or Problem Description
It was reported that some time post dialysis catheter placement, the catheter allegedly kinked.There was no reported patient injury.
Event or Problem Description
It was reported that during a catheter placement, the airguard introducer has allegedly kinked.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary:one hemostar xk long-term hemodialysis catheter was returned for evaluation.Functional and visual evaluation were performed.Both lumens were patent to infusion and aspiration without issue.The investigation is inconclusive for the reported introducer kinked, as no introducer kit was returned and the exact circumstances at the time of the reported event are unknown.A 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(expiry date: 08/2020),g4.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.

• Brand Name: HEMOSTAR XK LONG-TERM HEMODIALYSIS CATHETER, POLYURETHANE, 16F
• Common Device Name: CHRONIC VENOUS CATHETER HEMOSTAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10373324
• Report Number: 3006260740-2020-02810
• Device Sequence Number: 2476551
• Product Code: MSD
• UDI-Device Identifier: 00801741013607
• UDI-Public: (01)00801741013607
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K051748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2020

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: RECW0383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Initial Date Received by Manufacturer: 07/16/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 11/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1