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

Catalog Number	MX5341L
Medical Device Problem Codes	Crack (1135); Fracture (1260)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	08/21/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional Manufacturer Narrative
Other, other text: additional information is provided for h.2 and h.6.No product was returned.If the product is returned this complaint will be reopened for further investigation.No lot number was provided; therefore, a history record review could not be conducted.For all enquiries or follow-up questions related to the record, do not use regulatory.Responses@smiths-medical.Com located in sections g.1., please direct those to the following: regulatory.Responses@icumed.Com.

• Brand Name: SMALL BORE STOPCOCKS
• Common Device Name: 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
• Report Number: 3012307300-2023-08946
• Device Sequence Number: 6618287
• Product Code: FMG
• UDI-Device Identifier: 10351688506788
• UDI-Public: 10351688506788
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: MX5341L
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2023
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown