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

Catalog Number ZMC7401

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/25/2019

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 three units of stopcocks had cracked during use.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information :additional information : the actual and video of the sample was received for evaluation.A visual inspection was performed using the naked on the actual sample which revealed a crack in the luer.The video sample underwent visual inspection which revealed the stopcock was leaking from the middle inlet.The stopcock is not intended for use with syringe and it was not possible to insert the syringe fully as the customer had done.The reported condition was verified.The cause of the condition could not be clearly 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
• Manufacturer (Section G): BAXTER HEALTHCARE - MALTA; a47 industrial estate; marsa ; MT
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 9603543
• MDR Text Key: 175704191
• Report Number: 1416980-2019-07604
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/21/2020

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: ZMC7401
• Device Lot Number: 19D05V134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/25/2019
• Initial Date FDA Received: 01/17/2020
• Supplement Dates Manufacturer Received: 02/14/2020
• Supplement Dates FDA Received: 02/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 52 YR