MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION COUPLER ACCESSORIES; FORCEPS

Catalog Number 519306001010

Device Problem Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Date 11/25/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the tips of a coupler forceps were bent.This was identified before shipment to hospital prior to use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Correction to d1, e1: initial reporter country, g3.G3: remove consumer, add foreign.The device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The tips aligned and the hole within the tips of the forceps aligned appropriately.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: COUPLER ACCESSORIES
• Type of Device: FORCEPS
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9526296
• MDR Text Key: 172907341
• Report Number: 1416980-2019-07169
• Device Sequence Number: 1
• Product Code: HTD
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 01/29/2020

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
• Device Operator: Other
• Device Catalogue Number: 519306001010
• Device Lot Number: SP19G26-1237206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 01/17/2020
• Supplement Dates FDA Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1