MAUDE Adverse Event Report: ST PAUL DELTEC GRIPPER MICRO NEEDLE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-3261-24
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	06/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that upon removal of a smiths medical deltec gripper micro needle from a patient, the safety function did not work.It was reported that the upper part of the needle detached without resistance leading to a needle stick to the clinician.Since the needle was contaminated, the clinical staff's blood was taken.There were no reported adverse effects.
Additional Manufacturer Narrative
Device evaluation- the device history record was reviewed for the reported lot number.The review showed no related observations identified to suggest the reported issue was observed during production.A portion of the used device was returned for evaluation.The infusion tubing and connector had been cut off so only the needle base was returned with metal needle still attached.Examination showed the needle base was separated into two components.The operator was able to reassemble the two components back together to form a needle base.Following the device instructions the operator was able to retract the metal needle into the safety mechanism.The metal needle was fully captured and the returned pieces of the device were found to function as specified during testing.During production, the gripper safety needles are sampled for functional testing (hinge activation testing) to verify the parts are free of damage and workmanship defects and the manufacturing procedures are being followed.The investigation determined the most likely cause of the issue was damage during use.

• Brand Name: DELTEC GRIPPER MICRO NEEDLE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10267771
• Report Number: 3012307300-2020-07235
• Device Sequence Number: 11494653
• Product Code: FPA
• UDI-Device Identifier: 10610586029844
• UDI-Public: 10610586029844
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K072059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2020

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: 12/11/2024
• Device Model Number: 21-3261-24
• Device Catalogue Number: 21-3261-24
• Device Lot Number: 3902639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 07/13/2020
• Supplement Report FDA Received Date: 11/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1