MAUDE Adverse Event Report: COVIDIEN 1/2ML INSULIN SYR 28G X 1/2 RP; SYRINGE, PISTON

Model Number	8881500014
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information and 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 reported, the needle kept falling off.

• Brand Name: 1/2ML INSULIN SYR 28G X 1/2 RP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 9746261
• Report Number: 1915484-2020-01137
• Device Sequence Number: 18975773
• Product Code: FMF
• UDI-Device Identifier: 10884521014893
• UDI-Public: 10884521014893
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 02/24/2020

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: 8881500014
• Device Catalogue Number: 8881500014
• Device Lot Number: 913351X
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 02/24/2020
• Patient Sequence Number: 1