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

Catalog Number	21-2965-24
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer has not yet returned the device to the manufacturer for device evaluation.When and 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 during deaccess of the deltec® gripper plus® safety needle, the needle was "pulled up through the safety of the device." according to the report, the safety of the device did not lock and needle went through the bottom of the plastic base and was fully exposed.It was reported that no medical intervention was required and that no patient or clinician injury occurred.

• Brand Name: DELTEC® GRIPPER PLUS® SAFETY NEEDLES
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6341362
• Report Number: 3012307300-2017-00501
• Device Sequence Number: 817273
• Product Code: FPA
• UDI-Device Identifier: 30610586027738
• UDI-Public: 30610586027738
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K021999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/25/2017

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 Expiration Date: 08/28/2021
• Device Catalogue Number: 21-2965-24
• Device Lot Number: 36X922
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2017
• Initial Report FDA Received Date: 02/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1