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

Model Number 8881511235

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Patient Involvement (2645)

Event Date 08/04/2020

Event Type  malfunction  

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 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
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• Manufacturer (Section G): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 10386024
• MDR Text Key: 202425736
• Report Number: 1915484-2020-01179
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 20884521014975
• UDI-Public: 20884521014975
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8881511235
• Device Catalogue Number: 8881511235
• Device Lot Number: 930168X
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/04/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1