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

Catalog Number MX934Z4LM

Device Problems Crack (1135); Insufficient Flow or Under Infusion (2182)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)

Event Date 05/10/2018

Event Type  Injury  

Manufacturer Narrative

See mfr: 3012307300-2018-02322.

Event Description

It was reported that the area where the medex¿ manifold connects to swan was cracked.It was "noted that patient's blood pressures were very low and dropping during change of shift report.Patient given albumin by day rn; patient placed into trendelenburg position.Pressures down to 60 over 40's and lower.Heart rate dropping.Noted while moving patient and directly checking lines that manifold had blood backing up through almost to where iv tubing was connected on other side.Noted wet area on bedding, mix of blood and iv fluids.The manifold was in place for 2 days." it was reported that there was no patient injury associated with this occurrence.

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
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): SMITHS MEDICAL, ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): DUBLIN SHARED SERVICES CENTER; 5200 upper metro place; suite 200; dublin OH 43017
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7598387
• MDR Text Key: 110970093
• Report Number: 3012307300-2018-02321
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 10351688504142
• UDI-Public: 10351688504142
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MX934Z4LM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 79 YR