MAUDE Adverse Event Report: BARD ACCESS SYSTEMS RELIANCE XK LONG-TERM HEMODIALYSIS CATHETER WITH AIRGUARD STANDARD KIT (16F) (ST; CATHETER, HEMODIALYSIS, IMPLANTED

Catalog Number	5323190
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint that part of the peel away sheath broke apart and left little shards of plastic on the catheter during insertion is inconclusive due to the sample condition.Six photographs of an airguard introducer sheath against a blue towel were provided for investigation.The photographs show that the sheath had been split.It appears that the valve split properly and remained attached between the tabs and the top cap.Blood residue was observed throughout the sample.The edges of the split sheath were smooth and consistent.What appeared to be a white piece of material was shown on the blue towel separate from the sheath.From the images provided, it could not be determined where or if the material was attached to the introducer sheath.The entire surface of the split introducer sheath was not captured in the provided photographs.Based on the evidence provided for investigation, the reported event could not be verified.A lot history review (lhr) of reay1190 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Facility reported to the sales rep that part of the peel away sheath broke apart and left little shards of plastic on the catheter during insertion.The healthcare professional had to "pick them out of the tract into the vein".No other information was provided or patient injury reported.

• Brand Name: RELIANCE XK LONG-TERM HEMODIALYSIS CATHETER WITH AIRGUARD STANDARD KIT (16F) (ST
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6341340
• Report Number: 3006260740-2017-00110
• Device Sequence Number: 528922
• Product Code: MSD
• UDI-Device Identifier: 00801741011986
• UDI-Public: (01)00801741011986(17)180630(10)REAY1190
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/27/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 5323190
• Device Lot Number: REAY1190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2017
• Initial Report FDA Received Date: 02/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1