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

Model Number	8881501400
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/21/2020
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 the plungers are not air tight and air is getting in the syringes.There was no patient harm.
Additional Manufacturer Narrative
A device history record (dhr) review of the reported lot no.833044x confirmed that the product was produced accomplishing quality requirements and released according to established procedures.The manufacturing site received sixty-seven packaged samples with this customer report.A complete investigation was performed.A visual inspection to the quality inspection standard was conducted.Hot core pin was identified on one of the syringe samples.No other issues were identified.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.The leak test was conducted using both a metal hub and a plastic hub.All sixty-seven syringe samples passed the leak testing.All 67 samples were tested and found to pass the leak testing.Without a failure to confirm the reported condition a more complete investigation cannot be performed to the full extent and the reported condition cannot be confirmed.A definitive root cause cannot be determined at this time.

• 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: 9779774
• Report Number: 1915484-2020-01139
• Device Sequence Number: 14115967
• Product Code: FMF
• UDI-Device Identifier: 10884521014053
• UDI-Public: 10884521014053
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 05/12/2020

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: 8881501400
• Device Catalogue Number: 8881501400
• Device Lot Number: 833044X
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/21/2020
• Supplement Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 03/03/2020
• Supplement Report FDA Received Date: 05/12/2020
• Patient Sequence Number: 1