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

Catalog Number 982312

Device Problem Difficult or Delayed Activation (2577)

Patient Problem No Consequences Or Impact To Patient (2199)

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

Manufacturer completed the entire form.Smiths medical has received the sample device.A full evaluation 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 evaluation once it is completed.

Manufacturer Narrative

Device eval: four unused samples were returned for eval.Functional testing to engage the safety was performed on each unit.Needle was fully engaged into the safety mechanism without issue.Reporter contacted smiths medical following initial complaint info informing us that the issue was due an education need of clinicians.No problem found with unused sample returned for eval.

• Brand Name: SAF-T WING BLOOD COLLECTION & INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL, INC.; keene NH
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC; 10 bowman dr; keene NH 03431
• Manufacturer Contact: michele seliga ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287604
• MDR Report Key: 4782186
• MDR Text Key: 5802397
• Report Number: 2183502-2015-00336
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K895481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2020
• Device Catalogue Number: 982312
• Device Lot Number: 2931907
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/04/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/08/2015
• Device Age: 2 MO
• Event Location: Hospital
• Date Manufacturer Received: 04/24/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/12/2015
• 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