MAUDE Adverse Event Report: COVIDIEN 3ML SYRINGE 20G X 1 1/2 RP; SYRINGE, PISTON

Model Number	8881513058
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/19/2019
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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer states the syringes are found broken when the package is opened.

• Brand Name: 3ML SYRINGE 20G X 1 1/2 RP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 8605173
• Report Number: 1017768-2019-00638
• Device Sequence Number: 3030617
• Product Code: FMF
• UDI-Device Identifier: 20884521012674
• UDI-Public: 20884521012674
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/13/2019

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: 8881513058
• Device Catalogue Number: 8881513058
• Device Lot Number: 835325
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 05/13/2019
• Patient Sequence Number: 1