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

Catalog Number 982106

Device Problem Difficult or Delayed Activation (2577)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2014

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

Mfr completed the entire form.Add'l mfr 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 wil file a follow up report detailing the results of the eval once it is completed.Explanation of method: a sample device was returned and is currently in transit to the investigation site.

• 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
• 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: 3856294
• MDR Text Key: 18065201
• Report Number: 2183502-2014-00198
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K895481
• 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: 04/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 982106
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/08/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/09/2014
• Distributor Facility Aware Date: 03/06/2014
• Event Location: Hospital
• Date Manufacturer Received: 03/11/2014
• Was Device Evaluated by Manufacturer?: No
• 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