MAUDE Adverse Event Report: SMITHS HEALTHCARE MFG DELTEC® GRIPPER PLUS® SAFETY NEEDLES; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-2961-24
Medical Device Problem Codes	Difficult to Remove (1528); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event date: (b)(6) 2016.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 a deltec® gripper plus® safety needle was difficult to take out of the port due to tightness and when it was removed forcefully, the safety did not function.This was observed immediately upon use with a patient.It was noted that the device was check in accordance with its instructions for use.No patient injury was reported.
Additional Manufacturer Narrative
One device was returned for evaluation in used condition without its original packaging.Visual inspection found the safety mechanism had been activated and the needle was out of the base.It was observed that at the back of the arm, a white color was found on one of the sides.Functional testing involved use testing and found that the safety mechanism was able to be activated again without problem.A review of the testing and inspection documents was performed and deemed adequate and correct.A review of the manufacturing process was performed on a similar part and found no discrepancies.A sample of 32 devices underwent visual inspection and 5 devices underwent hinge activation testing, which found no discrepancies.A sample of 2 devices were destructively tested via excessive force and found a white color was presented at the damage, similar to the complaint device.Based on the evidence, a root cause was unable to be confirmed.The most likely root cause is attributed to failure outside of the manufacturing facility.

• Brand Name: DELTEC® GRIPPER PLUS® SAFETY NEEDLES
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS HEALTHCARE MFG; s.a. de c.v. ave calidad no. 4; parque industrial internaciona; tijuana, 22425 ; MX 22425
• MDR Report Key: 6427449
• Report Number: 3012307300-2017-00735
• Device Sequence Number: 1102380
• Product Code: FPA
• UDI-Device Identifier: 10610586027697
• UDI-Public: 10610586027697
• 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: company representative,foreig
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 21-2961-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2017
• Supplement Date Received by Manufacturer: 10/09/2017
• Initial Report FDA Received Date: 03/23/2017
• 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