MAUDE Adverse Event Report: COVIDIEN 1ML SAF SYR ETB 25X 5/8; SYRINGE, PISTON

Model Number	8881511235
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/04/2020
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
The customer stated that there is a substance or debris inside the needle/syringe.The customer stated this issue was identified prior to use.

• Brand Name: 1ML SAF SYR ETB 25X 5/8
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 10386024
• Report Number: 1915484-2020-01179
• Device Sequence Number: 13881168
• Product Code: FMF
• UDI-Device Identifier: 20884521014975
• UDI-Public: 20884521014975
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 08/10/2020

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: 8881511235
• Device Catalogue Number: 8881511235
• Device Lot Number: 930168X
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2020
• Initial Report FDA Received Date: 08/10/2020
• Patient Sequence Number: 1