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

Catalog Number	21-2760-24
Medical Device Problem Codes	Fail-Safe Design Failure (1222); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	07/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during use of this gripper plus® safety needle, upon removal of the device, the locking mechanism did not click, the sharp was not contained, and the clinician was stuck with the needle.This device was used to administer an infusion of chemotherapy.A pressure device was not used in conjunction.The event is being dealt with in hospital as per policy.No other adverse patient effects were reported.
Additional Manufacturer Narrative
The reporter noted that the previous lot number provided was incorrect.
Event or Problem Description
The needle was being used on a patient port at the time of the event.No medical intervention was performed.
Additional Manufacturer Narrative
Smiths medical received one gripper plus® safety needle inside a plastic bag in a used condition.Upon visual inspection of the safety needle the safety mechanism was noted to be inactivated and the needle does not have the protector; sample free from damage or broken components.Relevant documents (bonding procedure, assembly procedure) were reviewed along with operations were reviewed (base assembly, bin holding, component assembly) and found no discrepancies.A sample of (b)(4) units were inspected in order to verify for damages in the base with no discrepancies detected.Hinge activation testing was performed on five samples from the inventory and all successfully passed.Instructions for use was reviewed, a note of warning describes the care that must be taken when using the gripper plus with no fault found.Based on the evidence, the root cause cannot be determined due to the fact the safety mechanism was successfully activated.

• Brand Name: 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: 6804976
• Report Number: 3012307300-2017-01802
• Device Sequence Number: 1540613
• Product Code: FPA
• UDI-Device Identifier: 10610586025532
• UDI-Public: 10610586025532
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K021999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/08/2018

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?: No
• Operator of Device: Nurse
• Device Expiration Date: 06/28/2021
• Device Catalogue Number: 21-2760-24
• Device Lot Number: 36X631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2017
• Supplement Date Received by Manufacturer: 08/19/2017; 01/04/2018
• Initial Report FDA Received Date: 08/18/2017
• Supplement Report FDA Received Date: 09/12/2017; 01/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CHEMOTHERAPY
• Outcome Attributed to Adverse Event: Other