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

Model Number MX5341L

Device Problem Disconnection (1171)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Ninety-nine (99) unused product samples were received for evaluation, however the two (2) reported used devices were not returned.Visual and functional testing were performed on ten (10) randomly selected returned samples.Visual inspection found no issues.Functional testing found no issues.The tested devices functioned as intended, thus the root cause of the reported issue could not be determined.The reported issue does not provide significant detail as to what the nature of the defect was or what occurred.It is unclear if the tubing came out of it's bonded luer or if the tubing came off of the attached locknut on one of the stopcocks.It is possible that the complaint is indicating a cracked port that allowed the product to leak or become completely detached.The customer has been reached out to with a series of questions to provide additional details on the complaint; as of now there has been no response though this complaint can be re-opened in the future if more information is received.No product information has been provided to date.

Event Description

It was reported that two stopcocks came apart.The umbilical artery catheters (uac) remained in place and bleeding occurred because the tubing became disconnected at the stopcocks.No patient injury was reported.

• Brand Name: MEDEX SMALL BORE STOPCOCK
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; unit 2; minneapolis, MN 55442
• MDR Report Key: 15254968
• MDR Text Key: 305181972
• Report Number: 3012307300-2022-15635
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 10351688506788
• UDI-Public: 10351688506788
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MX5341L
• Device Catalogue Number: MX5341L
• Device Lot Number: 4183226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1