MAUDE Adverse Event Report: COVIDIEN SYRINGE INSULIN 1ML MONOJECT TIP CAP; SYRINGE, PISTON

Model Number	1188100777
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2021
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 the plungers get stuck during injections and they are having to discard the entire syringe.There was no patient injury.
Event or Problem Description
The customer reported that the plungers get stuck during injections and they are having to discard the entire syringe.There was no patient injury.Additional information provided on april 13, 2021 stated that they were referred by both medline and cardinal health to use these syringes when bd discontinued the syringes they were previously using when doing fat grafting.The doctor was willing to give these a try as they were told by both companies that these would be a suitable replacement but when using them, the black rubber stopper would turn sideways when pushing the plunger forward.They tried using cannulas to reach up inside the back end of the syringe to straighten the stopper again but it was not working well.They wasted tons of fat they had worked hard to retrieve because of the issue.

• Brand Name: SYRINGE INSULIN 1ML MONOJECT TIP CAP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 11649362
• Report Number: 1915484-2021-01226
• Device Sequence Number: 3355986
• Product Code: FMF
• UDI-Device Identifier: 10884521013704
• UDI-Public: 10884521013704
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2021

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: 1188100777
• Device Catalogue Number: 1188100777
• Device Lot Number: 014367X
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 04/20/2021
• Patient Sequence Number: 1