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

Catalog Number 2C6204

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

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that eight (8) large bore 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

H10: eight (8) actual samples were received for evaluation.Visual inspection was performed which observed that one sample was wrinkled and there was a part of the blister package seal that was opened.A bubble test was performed on each received sample which revealed a leak in the seal of only one sample.The reported condition was verified in one sample; however, not verified in the remaining seven samples.The cause of the condition could not be determined.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
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 12084909
• MDR Text Key: 258928198
• Report Number: 1416980-2021-03969
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00085412001913
• UDI-Public: (01)00085412001913
• Combination Product (y/n): Y
• PMA/PMN Number: K130245
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/05/2021

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: 2C6204
• Device Lot Number: UR20B06058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2021
• Date Manufacturer Received: 08/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1