MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. DELTEC® GRIPPER PLUS® SAFETY NEEDLE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-2768-24
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/27/2017
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
It was reported that the safety mechanism of a deltec® gripper plus® safety needle failed during use.The nurse was able to get the safety "back to where it's supposed to be".No injury to patient or clinician was reported.
Additional Manufacturer Narrative
One device was reported for evaluation in used condition and without its original packaging.Visual inspection found that the safety mechanism had been activated and the needle was out of its base.It was observed at the back of the arm that there was a white color and it was observed that the hinge was misaligned.Functional testing involved use testing and found that the safety mechanism was able to be activated without problem with the hinge aligned.A review of the testing and inspection documents was performed and deemed adequate and correct.A review of the manufacturing process for a similar part and found no discrepancies.Visual inspection of 32 sample devices and hinge activation of 5 sample devices was performed and found no discrepancies.Destructive testing of 2 sample devices was performed and found excessive force application showed a white color similar to the complaint device.Based on the evidence, no fault was found with the complaint device and the root cause was unable to be determined.The most probable root cause is related to a failure outside the manufacturing facility.

• Brand Name: DELTEC® GRIPPER PLUS® SAFETY NEEDLE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6584783
• Report Number: 3012307300-2017-01068
• Device Sequence Number: 92257
• Product Code: FPA
• UDI-Device Identifier: 10610586025648
• UDI-Public: 10610586025648
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K021999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Nurse
• Device Catalogue Number: 21-2768-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2017
• Supplement Date Received by Manufacturer: 10/09/2017
• Initial Report FDA Received Date: 05/23/2017
• Supplement Report FDA Received Date: 10/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1