MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. DELTEC® GRIPPER PLUS® SAFETY NEEDLE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	21-2770-24
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the event occurred in (b)(6) 2017.The exact date is unknown.Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
Event or Problem Description
It was reported that the needle stick prevention mechanism of a deltec® gripper plus® safety needle did not work, and the needle could not be stowed in the product.Another needle was used.No injury was reported.
Additional Manufacturer Narrative
One used device and one syringe were received for investigation.The samples were visually inspected and no discrepancies were found.Functional testing was performed and the safety mechanism of the device was able to be activated.A manufacturing review was performed and no discrepancies were found in the tested samples.As the complaint could not be confirmed, no root cause could be determined.

• Brand Name: DELTEC® GRIPPER PLUS® SAFETY NEEDLE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6732395
• Report Number: 3012307300-2017-01561
• Device Sequence Number: 762309
• Product Code: FMI
• UDI-Device Identifier: 10610586025631
• UDI-Public: 10610586025631
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K021999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2018

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: No Information
• Device Expiration Date: 08/28/2021
• Device Catalogue Number: 21-2770-24
• Device Lot Number: 36X824
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2017
• Supplement Date Received by Manufacturer: 04/12/2018
• Initial Report FDA Received Date: 07/21/2017
• Supplement Report FDA Received Date: 05/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1