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

Catalog Number MX5341L

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 10/26/2023

Event Type  malfunction  

Event Description

It was reported that the "3 way stopcock came out apart during contrast pump injection".Adverse effects are unknown.

Manufacturer Narrative

Other text: g5: 510k is blank, no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Manufacturer Narrative

No product or photographic evidence were provided to aid in this investigation.The complaint report offered insufficient details to determine whether this product functioned as intended or was used in a manner consistent with its instructions for use (ifu) or failed to meet product specifications.Lacking any additional evidence, this complaint has been closed as unconfirmed.If the product is returned, icu medical will reopen this complaint for further investigation.A device history (dhr) review was performed subsequent to the manufacturing of the device and prior to its release.No problems or issues were identified during this dhr review.For all enquiries or follow-up questions related to the record, do not use (b)(6) located in sections g.1., please direct those to the following: (b)(6).

• Brand Name: MEDEX SMALL BODY STOPCOCKS
• Type of Device: STOPCOCK I.V. SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 18142795
• MDR Text Key: 328371102
• Report Number: 3012307300-2023-10516
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 10351688506788
• UDI-Public: 10351688506788
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MX5341L
• Device Lot Number: 4393604
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1