MAUDE Adverse Event Report: ST PAUL DELTEC; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	21-3251-24
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	12/24/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device had been in use with patient and user had captured the needle in the safety mechanism.Reporter stated the needle came out of the safety mechanism and user sustained needle stick.User was given user facility's needle stick protocol.Further information has been requested and not received at this time.
Additional Manufacturer Narrative
Other, other text: returned device was received for evaluation.During the evaluation of the device the customer reported condition was not confirmed.No fault found.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.

• Brand Name: DELTEC
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 11287959
• Report Number: 3012307300-2021-00927
• Device Sequence Number: 14414395
• Product Code: FPA
• UDI-Device Identifier: 10610586029745
• UDI-Public: 10610586029745
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K072059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2021

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 Model Number: 21-3251-24
• Device Catalogue Number: 21-3251-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/08/2021
• Supplement Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 02/05/2021
• Supplement Report FDA Received Date: 03/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1