MAUDE Adverse Event Report: SMITHS MEDICAL, INC. SAF-T WING BLOOD COLLECTION AND INFUSION SET

Catalog Number 982312

Device Problem Difficult or Delayed Activation (2577)

Patient Problem Needle Stick/Puncture (2462)

Event Type  Injury  

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.The pt moved which caused the clinician to endure a needle stick.

Manufacturer Narrative

Smiths med 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 med will file a follow-up report detailing the results of the eval once it is completed.

Manufacturer Narrative

Device eval: (b)(4) unused samples were returned for eval.Visual inspection observed the needles to be fully retracted.Investigators were able to force two of the four sample needles out of the safety mechanism to perform functional testing.Samples passed the pull test and audible "click" sound was heard.Reporter contacted smiths medical following initial complaint notification informing us that the issue was due to an education need of clinicians.No problem found with samples returned for eval.

• Brand Name: SAF-T WING BLOOD COLLECTION AND INFUSION SET
• 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: 4774946
• MDR Text Key: 5782860
• Report Number: 2183502-2015-00341
• 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: 05/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 05/11/2015
• Device Age: 1 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
• Patient Outcome(s): Other