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

Catalog Number MX2341L

Device Problem Crack (1135)

Patient Problem Blood Loss (2597)

Event Date 07/08/2017

Event Type  Injury  

Manufacturer Narrative

It was reported that the patient was an infant.Exact age was not provided.

Event Description

It was reported that the hub of a medex¿ small bore stopcock cracked.The patient lost 10-15 cc of blood.Reporter indicated that intervention was required but no details of the intervention were provided.No permanent injury was reported.

Event Description

It was additionally reported that the intervention provided to the patient was intubation, blood transfusion, and a transfer to higher level of care.The outcome of the event is unknown.

• Brand Name: MEDEX¿ SMALL BORE STOPCOCK
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7252515
• MDR Text Key: 99373891
• Report Number: 3012307300-2018-00224
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 10351688508324
• UDI-Public: 10351688508324
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/03/2018

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
• Device Operator: No Information
• Device Expiration Date: 08/13/2019
• Device Catalogue Number: MX2341L
• Device Lot Number: 3276045
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/29/2018
• Initial Date FDA Received: 02/08/2018
• Supplement Dates Manufacturer Received: 03/09/2018
• Supplement Dates FDA Received: 04/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2016
• 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): Life Threatening; Required Intervention