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

Model Number 8881600350

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2020

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. as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reported that there were black spots/particles inside of the product.It was noticed on the cap/tip after use.

Event 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.

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
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 10089554
• MDR Text Key: 195476231
• Report Number: 1915484-2020-01169
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30884521014927
• UDI-Public: 30884521014927
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: No Information
• Device Model Number: 8881600350
• Device Catalogue Number: 8881600350
• Device Lot Number: 926641X
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/20/2020
• Initial Date FDA Received: 05/26/2020
• Supplement Dates Manufacturer Received: 05/20/2020
• Supplement Dates FDA Received: 06/03/2020
• Patient Sequence Number: 1