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	Needle Stick/Puncture (2462)
Date of Event	04/18/2017
Type of Reportable Event	Serious Injury
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 needle shield of a deltec® gripper plus® safety needle did not cover the needle as it was supposed to, leaving the needle outside the shield."ee" had flushed the port with ns and heparin.Clinician stabilized the port and was retracting the needle when they were stuck in the right thumb.Clinician went to employee health to have it checked out.Lab work and risk counseling was done.No permanent injury was reported, and the event was reported as resolved.
Additional Manufacturer Narrative
One used deltec® gripper plus® safety needle was returned for investigation.A visual inspection was performed and it was noted that the safety mechanism had already been activated and the needle was out of the base.On the back of the arm, discoloration was found on one of the sides.Functional testing revealed it was possible for the safety arm to be activated again.A manufacturing review of a similar device found no discrepancies.The complaint was not confirmed.The most probable root cause was determined to be that the damage to the safety arm occurred after the product left 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: 6570474
• Report Number: 3012307300-2017-01032
• Device Sequence Number: 16163588
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 21-2768-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2017
• Supplement Date Received by Manufacturer: 10/09/2017
• Initial Report FDA Received Date: 05/16/2017
• Supplement Report FDA Received Date: 10/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR
• Patient Weight: 103