MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION STOPCOCK MANIFOLD GANGS; STOPCOCK, I.V. SET

Catalog Number 2C5603

Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/04/2021

Event Type  malfunction  

Manufacturer Narrative

The devices were received and are currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that forty-eight (48) 3 way stopcocks were defective.The defect was further described as packaging was not sterile, air leak from the side of the sealed edge.This issue was identified prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Forty-five (45) actual devices were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A bubble test was performed on each received sample and no defects or seal damage was identified.The reported condition was not verified on the forty-five (45) received samples.The remaining three (3) devices were not received; therefore, a device analysis could not be completed for those samples.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: STOPCOCK MANIFOLD GANGS
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 12085044
• MDR Text Key: 258936480
• Report Number: 1416980-2021-03976
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): Y
• PMA/PMN Number: K962581
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C5603
• Device Lot Number: GR296756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• Date Manufacturer Received: 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1