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

The user facility reported that following use of the device, the needle could not be fully retracted into the safety mechanism.While attempting to engage the safety mechanism, a nurse suffered a dirty needle stick.A product rep reportedly met with the user facility and determined that the clinicians were using the devices incorrectly, causing difficulty in engaging the safety mechanism.

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for device eval.When and if the device becomes available and is returned and evaluated the manufacturer will file a f/u report detailing the results of the 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: 4808785
• MDR Text Key: 5924835
• Report Number: 2183502-2015-00366
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2015
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/26/2015
• Device Age: 2 MO
• Event Location: Hospital
• Date Manufacturer Received: 05/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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