MAUDE Adverse Event Report: COVIDIEN 1ML TB SYRINGE REGULAR LUER RP; SYRINGE, PISTON

Model Number	8881501400
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2021
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 when the syringe plunger is pulled back, it cannot be depressed afterwards to give injection.No patient injury was reported.
Additional Manufacturer Narrative
A device history record review of the reported lot confirmed that the product was produced accomplishing quality requirements and released according to established procedures.The manufacturing site received six samples with this customer report.Three of the samples were packaged and three were unpackaged.A complete investigation was performed including a visual inspection to the quality inspection standard was conducted and nothing appeared to be out of specification.The lab performed plunger activation force testing on all six syringe samples received.All six samples passed the plunger movement force testing with results that ranged from 0.58 ¿ 0.86 lbf.The specification limit for the plunger movement force testing is nmt 1.12 lbf, therefore all results are well within specifications.Leak testing was performed.The leak test is conducted to verify the syringe draws, holds, and expels fluid properly by inserting the syringe into a rubber block for resistance.All six syringes passed the leak testing.Process controls are in place to prevent the occurrence and acceptance of the reported conditions during the molding, printing, assembly, and packaging processes, and to ensure components and finished product that meet all quality inspection standards during the syringe assembly processes.The manufacture of all molded, printed, assembled, and packaged product is conducted within a validated process, inside a controlled manufacturing area.

• Brand Name: 1ML TB SYRINGE REGULAR LUER RP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 11516802
• Report Number: 1915484-2021-01222
• Device Sequence Number: 4087897
• Product Code: FMF
• UDI-Device Identifier: 10884521014053
• UDI-Public: 10884521014053
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2021

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: 8881501400
• Device Catalogue Number: 8881501400
• Device Lot Number: 020250X
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 05/17/2021
• Patient Sequence Number: 1