MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC. MEDEX¿ SMALL BORE STOPCOCKS; STOPCOCK, I.V. SET

Catalog Number MX5311L

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/04/2016

Event Type  malfunction  

Manufacturer Narrative

The device is currently being evaluated; the manufacturer will file a follow-up report detailing the results of the evaluation once it is completed.

Event Description

It was reported that medex small bore stopcocks had the white valve pop off during use.No injury was reported.

Manufacturer Narrative

Two stopcock bodies and one stopcock plug were returned for investigation.The customer reported that five devices contributed to five reported events (one device per event).It could not be determined which returned device was associated with which reported occurrence; therefore, the evaluation of the returned devices will be used for this medwatch.A review of the device history record, for the relevant lot, found no dimensional or functional issues for the body or the assembly.Visual inspection found that the returned stopcock bodies were both a number 8 and the returned stopcock plug was a number 10.Further inspection revealed that the stop on the stopcock plug and the tabs of the bodies were damaged.The damage observed was consistent with the stop being violated and the handle being turned in a direction not intended based on its design.During functional testing, one of the returned stopcock bodies and the returned plug were re-assembled and the force required to dissemble the device was measured; three separate trials were conducted.The force required to disassemble the stopcock body and plug, for all three trials, was found to be within manufacturing specification.The additional returned stopcock body was inserted with three new plugs, heat conditioned (to simulate sterilization) and then the force required to disassemble the stopcocks was measured; all three trials were found to be within specification.No fault was found with the returned devices based upon the re-assembly functional testing.Investigation determined the root cause of the valve popping off was due to misuse of the device.(b)(4).

• Brand Name: MEDEX¿ SMALL BORE STOPCOCKS
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): SMITHS MEDICAL ASD INC.; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): SMITHS MEDICAL ASD INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: lisa perz ; 1265 grey fox rd.; st. paul, MN 51122 ; 7633833074
• MDR Report Key: 5921309
• MDR Text Key: 53711303
• Report Number: 2183502-2016-01872
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: MX5311L
• Device Lot Number: 3168078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2016
• 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