MAUDE Adverse Event Report: SMITHS MEDICAL ASD 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 Date 10/16/2015

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

It was reported that during use the needle sheared through the protective sheath during insertion.As a result, the needle was not able to be placed in the safety mechanism.No adverse health outcome resulted from this event.

Manufacturer Narrative

One opened sample was returned for evaluation.Visual inspection did not reveal product damage.The safety mechanism was found activated and the needle engaged inside.During functional testing, the needle was pushed out of the safety mechanism and the device was pull tested to measure the amount of force required to re-engage the needle into its safety mechanism.The amount of force was found to be out of manufacturing specification (0.5 lbf < x < 1.5 lbf).To test further, thirty-two units were taken from the production floor and pull tested.All samples were found to operate as intended; the force required to engage the safety mechanisms was in specification.The exact root cause for the returned sample's safety mechanism operating outside of specification could not exactly be determined; a potential cause is related to a supplier manufacturing issue.A supplier notification was issued to the product supplier notifying them of the received product complaint and a request to review current processes.In addition, production personnel were notified of the report to heighten awareness of this issue.

• Brand Name: SAF-T WING BLOOD COLLECTION & INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD INC.; 10 bowman drive; keene NH 03431
• Manufacturer (Section G): SMITHS MEDICAL ASD INC.,; 10 bowman drive; keene NH 03431 0724
• Manufacturer Contact: michele seliga ; 1265 grey fox rd.; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5243247
• MDR Text Key: 31908392
• Report Number: 2183502-2015-00903
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 11/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2020
• Device Catalogue Number: 982312
• Device Lot Number: 3022795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/02/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/29/2015
• 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