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

Catalog Number MX5341L

Device Problems Crack (1135); Fracture (1260)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 08/21/2023

Event Type  malfunction  

Manufacturer Narrative

Other, other text: d4: lot number, expiration date, udi number and h4: device manufacture date is unknown, no information has been provided to date.G5: 510k is blank, device is exempt.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.

Event Description

It was reported that there was an increased presser requirement and escalation of care.The patient went for emergent computerized tomography (ct), and question of whether or not going to the operating room (or) after.Upon return from computerized tomography (ct), it was noticed the patients gown was wet.It appeared the stopcock had a crack in it and was changed immediately upon inspection.After changing the stopcock with the pressers attached, the patient became hypertensive, thus decreasing a large need for the pressers.

• Brand Name: SMALL BORE 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: 17761105
• MDR Text Key: 324063713
• Report Number: 3012307300-2023-08946
• 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: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MX5341L
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1