MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX EXTENSION SET HI-FLOW STOPCOCKS; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	MX413SL
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: b3: date of event, d4: lot number, expiration date, g5: 510k, and h4: manufacture date are unknown, 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.
Event or Problem Description
It was reported that there was a crack and breakage noted at the male end of the tubing.Patient involvement is unknown.Adverse effects have not been reported.
Additional Manufacturer Narrative
Device evaluation: one device was returned for investigation.Visual inspection observed that the tip of slide swivel was broken.Under a microscope found a deformation in the broken section of the tip.The complaint was confirmed.The root cause was related to mishandling of the product.No lot number was reported therefor a device history report (dhr) review could not be performed.This issue will continue to be monitored and further actions taken accordingly.

• Brand Name: MEDEX EXTENSION SET HI-FLOW STOPCOCKS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 17307686
• Report Number: 3012307300-2023-07140
• Device Sequence Number: 7213551
• Product Code: FPA
• UDI-Device Identifier: 10351688507822
• UDI-Public: 10351688507822
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2023

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 Model Number: MX413SL
• Device Catalogue Number: MX413SL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2023
• Supplement Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 08/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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