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

Catalog Number MX5311L

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

Upon analysis of the returned device, no problem was confirmed.The plugs had been turned beyond the stop tabs of the body causing damage that lead to the plugs coming out.This could not occur prior to use, as it happens while the plug is actively being turned.The product was used in a manner inconsistent with the intuitive use of the device.

Event Description

User facility reported that the stopcock lever popped out of the device and fell apart prior to use.The stopcock handle was found lying in the patient/child's bed.No adverse health outcome was reported.

• Brand Name: MEDEX¿ SMALL BORE STOPCOCKS
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): SMITHS MEDICAL ASD INC; 6250 shier rings rd.; dublin OH 43016
• Manufacturer (Section G): SMITHS MEDICAL ASD INC; 6250 shier rings rd.; dublin OH 43016
• Manufacturer Contact: lisa perz ; 1265 grey fox road; st paul 55112 ; 7633833074
• MDR Report Key: 5771155
• MDR Text Key: 48812746
• Report Number: 2183502-2016-01334
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: MX5311L
• Device Lot Number: 3162715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1