MAUDE Adverse Event Report: COVIDIEN 1/2ML INSULIN SYR 29G X 1/2 SP; SYRINGE, PISTON

Model Number	8881600350
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/20/2020
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. 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 that there were black spots/particles inside of the product.It was noticed on the cap/tip after use.
Event or Problem Description
The customer reported that there were black spots/particles inside of the product.It was noticed on the cap/tip after use.On (b)(6) 2020 the customer confirmed that the spots/particles were only located on the inside and outside of the cap.The customer stated that no spots/particles were located on or in the needle, hub or syringe.
Additional Manufacturer Narrative
Based on the additional information received, this incident has been deemed a non-reportable product malfunction.Please disregard report number 1915484-2020-01169.

• Brand Name: 1/2ML INSULIN SYR 29G X 1/2 SP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 10089554
• Report Number: 1915484-2020-01169
• Device Sequence Number: 2924365
• Product Code: FMF
• UDI-Device Identifier: 30884521014927
• UDI-Public: 30884521014927
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2020

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: 8881600350
• Device Catalogue Number: 8881600350
• Device Lot Number: 926641X
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 05/20/2020
• Initial Report FDA Received Date: 05/26/2020
• Supplement Report FDA Received Date: 06/03/2020
• Patient Sequence Number: 1