MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC MEDEX¿ 4 WAY HI-FLO¿ STOPCOCK W/ LOCKNUT; STOPCOCK, I.V. SET

Catalog Number BPP9341LG2

Device Problems Disconnection (1171); Connection Problem (2900)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during set up, when connecting the male end of the stopcock to the top of an arterial filter, the tap would not lock properly.During priming it popped off.The product was replaced with another manufacturer's stopcock for the case.There was no patient involvement.

• Brand Name: MEDEX¿ 4 WAY HI-FLO¿ STOPCOCK W/ LOCKNUT
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD INC; 6250 shier rings rd.; dublin OH 43016
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6034161
• MDR Text Key: 57862603
• Report Number: 3012307300-2016-00110
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: MX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/20/2016

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: Health Professional
• Device Expiration Date: 10/21/2020
• Device Catalogue Number: BPP9341LG2
• Device Lot Number: 3069349
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/20/2016
• Initial Date FDA Received: 10/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2015
• 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