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

Catalog Number	21-2766-24
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is same and/or similar to a device approved for distribution in the us.
Event or Problem Description
It was reported that the "needle prick prevention function" of a deltec® gripper plus® safety needle did not work.The fault occurred while removing the needle from the patient after "the needle base was unable to be lowered".No injury to patient or clinician was reported.
Additional Manufacturer Narrative
A deltec® gripper safety needle was returned for analysis in used condition.The customer's reported problem was "the needle-prick prevention function did not work".The sample was visually inspected for damage at a distance of 12" to 24" under normal conditions of illumination.The sample was received with the safety mechanism inactivated and with solvent in the arm of the safety mechanism.The arm of the ay base of the sample was pulled in order to verify that the safety mechanism could be activated.The safety mechanism could not be activated.The manufacturing and quality inspection processes were reviewed and considered adequate and correct.The most probable root cause of the reported problem could have been a manufacturing error at the assembly process by applying excess solvent at an incorrect location.
Event or Problem Description
It was additionally reported that the device was being used to deliver an anti-cancer drug.The patient was going to take the anti-cancer drug home and take it for 46 hours, and changed the needle and administered the drug.Unnecessary additional puncture was required.

• 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: 7332068
• Report Number: 3012307300-2018-00494
• Device Sequence Number: 110534
• Product Code: FPA
• UDI-Device Identifier: 10610586025594
• UDI-Public: 10610586025594
• 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,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/20/2018

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: 10/23/2022
• Device Catalogue Number: 21-2766-24
• Device Lot Number: 37X1416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2018
• Supplement Date Received by Manufacturer: 02/22/2018; 05/21/2018
• Initial Report FDA Received Date: 03/12/2018
• Supplement Report FDA Received Date: 03/22/2018; 06/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1