MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL LTD. SAF-T WING BLOOD COLLECTION AND INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 982106L

Device Problem Difficult or Delayed Activation (2577)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/31/2014

Event Type  malfunction  

Event Description

A report was received stating that following use of the device, the needle could not be fully retracted into the safety mechanism, leaving the needle exposed.There was no pt or clinician injury reported.

Manufacturer Narrative

Smiths medical has received the sample device.A full eval is anticipated, but not yet begun as the device is currently in transit to the investigation site.Smiths medical will file a follow-up report detailing the results of the eval once it is completed.

• Brand Name: SAF-T WING BLOOD COLLECTION AND INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL LTD.; hythe, kent ; UK
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer Contact: pete hirte ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 4080217
• MDR Text Key: 4746957
• Report Number: 2183502-2014-00616
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 08/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2016
• Device Catalogue Number: 982106L
• Device Lot Number: 2602651
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/05/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/19/2014
• Distributor Facility Aware Date: 07/31/2014
• Device Age: 9 MO
• Event Location: Hospital
• Date Manufacturer Received: 08/01/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1