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

Catalog Number	21-2966-24
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/27/2016
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 use the needle would not engage into the safety mechanism.Resistance was felt upon pulling the needle into the mechanism.No adverse health outcome resulted from this event.
Additional Manufacturer Narrative
(b)(4).One used deltec® gripper plus® safety needle was returned for investigation.A review of the device history record was performed and no discrepancies or anomalies were found.A visual inspection was performed and it was observed that a portion of the safety arm presented excess solvent and appeared to be adhered to the base.Functional testing was performed and excessive force was required to activate the safety mechanism, which resulted in the device breaking.The complaint was confirmed.A manufacturing review of a similar device was performed and no discrepancies were found.The most probable root cause was determined to be: the operator applied an excessive amount of solvent in the bonding between the gripper ay base and the tube and the base became adhered.The operator did not follow procedures and did not perform the visual inspection in order to detect excess solvent.

• Brand Name: GRIPPER PLUS SAFETY NEEDLE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR,
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 5673696
• Report Number: 2183502-2016-01071
• Device Sequence Number: 88640
• Product Code: FPA
• UDI-Device Identifier: 30610586027745
• UDI-Public: 30610586027745
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2017

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: Other
• Device Expiration Date: 11/28/2020
• Device Catalogue Number: 21-2966-24
• Device Lot Number: 35X1211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2016
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2016
• Supplement Date Received by Manufacturer: 08/22/2017
• Initial Report FDA Received Date: 05/23/2016
• Supplement Report FDA Received Date: 09/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1