MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GLIDEPATHHEMODIALYSISCATH; DIALYSIS CATHETER

Catalog Number 6393270

Device Problems Contamination /Decontamination Problem (2895); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation, however photos have been provided.The investigation of the reported event is currently underway.Expiry date: 10/2019.

Event Description

It was reported that sometime post dialysis catheter implant, the device allegedly had white material accumulation in external tubes.There was no reported patient injury.

Event Description

It was reported that sometime post dialysis catheter implant, the device allegedly had white material accumulation in external tubes.There was no reported patient injury.

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: the sample was not returned for evaluation, however, seven electronic photos were provided for review.Based on the photo review, white particulate within the catheter cannot be confirmed; the only photo showing the catheter which is consistent with the product for this complaint is not of sufficient detail to confirm particulate within the lumen.Therefore, this investigation is inconclusive.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: 10/2019),g4 h11: h6(device, result and conclusion) 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: GLIDEPATHHEMODIALYSISCATH
• Type of Device: DIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10198920
• MDR Text Key: 198680575
• Report Number: 3006260740-2020-02261
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741138515
• UDI-Public: (01)00801741138515
• Combination Product (y/n): N
• PMA/PMN Number: K051748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6393270
• Device Lot Number: RECV0452
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1