MAUDE Adverse Event Report: SMITHS MEDICAL, ASD, INC. MEDEX¿ MANIFOLD; STOPCOCK, I.V. SET

Catalog Number	MX934Z4LM
Medical Device Problem Codes	Crack (1135); Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	05/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
See mfr: 3012307300-2018-02321.
Event or Problem Description
It was reported that the second manifold, a medex¿ manifold, after 2 to 3 hours, of use also had cracked at cap side connection.Intravenous fluids and vasopressors leaked all over the bed and patient had loss of hemodynamic vitals.Patient had to be placed into trendelenburg position again with increase of drops (gtt).It was reported that there was no patient injury associated with this occurrence.
Additional Manufacturer Narrative
One used manifold was received for device evaluation.Visual inspection revealed a crack at the female luer of the stopcock body.Based on the available reported information, it was determined that the crack was likely caused by prolonged exposure to drug/medications.This product is not designed to be impervious to all drug/medications or combinations thereof.While no definitive root cause to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.

• Brand Name: MEDEX¿ MANIFOLD
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): SMITHS MEDICAL, ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7598330
• Report Number: 3012307300-2018-02322
• Device Sequence Number: 1186769
• Product Code: FMG
• UDI-Device Identifier: 10351688504142
• UDI-Public: 10351688504142
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: MX934Z4LM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2018
• Supplement Date Received by Manufacturer: 07/18/2018
• Initial Report FDA Received Date: 06/13/2018
• Supplement Report FDA Received Date: 07/25/2018
• 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: Life Threatening
• Patient Age: 79 YR