MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX¿ LARGE BORE - HI-FLO¿ STOPCOCK; STOPCOCK, I.V. SET

Catalog Number	MX934Z3LM
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
Event or Problem Description
It was reported that a medex¿ large bore - hi-flo¿ stopcock leaked and cracked when nurses hooked up the intravenous tubing.The product fault occurred while in use with a patient.Patient received a bolus of pressors to improve blood pressure due to the interruptions in therapy.No permanent injury was reported, and the outcome of the event was reported as resolved.

• Brand Name: MEDEX¿ LARGE BORE - HI-FLO¿ STOPCOCK
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6758112
• Report Number: 3012307300-2017-01608
• Device Sequence Number: 1080213
• Product Code: FMG
• UDI-Device Identifier: 10351688504159
• UDI-Public: 10351688504159
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Nurse
• Device Expiration Date: 04/03/2020
• Device Catalogue Number: MX934Z3LM
• Device Lot Number: 3401907
• 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: 07/12/2017
• Initial Report FDA Received Date: 08/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Weight: 70