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

Catalog Number 2C6204

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Suspected lot number: ur20i14016.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported a large bore stopcock disconnected.Approximately 2.25 hours into a prbc (packed red blood cells) transfusion, the stopcock ¿became spontaneously dislodged/unscrewed and blood began soaking the bed¿.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: the device was received for evaluation.A stopcock was received along with a non-baxter valve connector piece and this attached to a syringe.Additionally, individual non-baxter valve connector piece was received.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing, including clear passage and pressure testing were performed, and the device performed according to product specifications.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: STOPCOCK
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11051013
• MDR Text Key: 223161902
• Report Number: 1416980-2020-07951
• Device Sequence Number: 1
• Product Code: FMG
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2C6204
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Date Manufacturer Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRBC; PRBC
• Patient Age: 23 WK
• Patient Weight: 460