MAUDE Adverse Event Report: COVIDIEN PREVENT 3ML COMBO 25 X 5/8; SYRINGE, PISTON

Model Number	26549
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
Event or Problem Description
Customer reports: needles seem to be more flimsy and the safety feature does not securely lock leaving part of the needle exposed, which has led to needlesticks.
Additional Manufacturer Narrative
Corrected the facility name and address in section e.

• Brand Name: PREVENT 3ML COMBO 25 X 5/8
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 10622956
• Report Number: 1017768-2020-00875
• Device Sequence Number: 3649871
• Product Code: FMF
• UDI-Device Identifier: 10612479201115
• UDI-Public: 10612479201115
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2020

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 Model Number: 26549
• Device Catalogue Number: 26549
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/28/2020
• Supplement Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 10/02/2020
• Supplement Report FDA Received Date: 11/02/2020
• Patient Sequence Number: 1