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

Device Problems Entrapment of Device (1212); Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/18/2017

Event Type  malfunction  

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 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
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• 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. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 6341340
• MDR Text Key: 68084354
• Report Number: 3006260740-2017-00110
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741011986
• UDI-Public: (01)00801741011986(17)180630(10)REAY1190
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 01/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2016
• 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