MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX LARGE BORE - HI-FLO¿ STOPCOCKS, 4-WAY STOPCOCK; STOPCOCK, I.V. SET

Model Number MX934Z3LM

Device Problem Crack (1135)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 04/04/2016

Event Type  Injury  

Manufacturer Narrative

The device is currently being evaluated; the manufacturer will file a follow-up report detailing the results of the evaluation once it is completed.

Event Description

According to report from user facility, the listed stopcock cracked and leaked during infusion of medication into cardiac patient (patient was recovering from open heart surgery).The patient did not receive sufficient blood pressure medication (wrepio 0.12 mcg/kg/min).As a result, the patient's blood pressure dropped to 58/35 with a map of 49.Patient was given fluid until blood pressure rose.No permanent adverse effects to patient reported.

Manufacturer Narrative

The reported stopcock was returned for investigation that showed that the end port was fractured and when connected to a mating luer leaked at 45psi.The crack had two fracture lines initiating from the thinnest section of the thread and propagated to the main section of the body.Based on the visual, dimensional, and functional review no root cause could be determined for the failure mode of the cracked female port.All inspections and observation would suggest that the product was molded correctly and met the design specifications and thus would function according to designed intent.

• Brand Name: MEDEX LARGE BORE - HI-FLO¿ STOPCOCKS, 4-WAY STOPCOCK
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings rd.; dublin OH 43016
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6250 shier rings rd.; dublin OH 43016
• Manufacturer Contact: michele seliga ; 1265 grey fox road; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5640908
• MDR Text Key: 44727110
• Report Number: 2183502-2016-00937
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/09/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2018
• Device Model Number: MX934Z3LM
• Device Catalogue Number: MX934Z3LM
• Device Lot Number: 3066343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/11/2016
• Initial Date FDA Received: 05/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/04/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/10/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention