MAUDE Adverse Event Report: COVIDIEN 10ML STANDARD LUER LOCK SYRING; SYRINGE, PISTON

Model Number	1181200777K
Medical Device Problem Codes	Component Incompatible (1108); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2021
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 physicians feel that the rubber stopper on the plunger is not of best quality as previous syringes and they let air into the syringe.There was no patient injury reported.
Additional Manufacturer Narrative
Investigation summary: the supplier has reviewed the device history record for the reported lot and there were no deviations listed for this lot at the time of manufacturing.As samples were not returned for the complaint analysis, the supplier performed an investigation on retained samples from the same lot.The retained samples were found to be within the specifications during the visual and dimensional check, completed for the reported issue.A leakage test under compression in accordance to iso7886-1 was conducted; there was no air let into the syringe during the test and air was not visible between the seals of the gasket.Since the complained sample was not available and the investigation results on the retained samples were within the specifications and did not reveal air into the syringe, a root cause could not be identified.No new actions are required at this time.The complaint will be used for tracking and trending purposes.

• Brand Name: 10ML STANDARD LUER LOCK SYRING
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11733066
• Report Number: 1282497-2021-10116
• Device Sequence Number: 14476203
• Product Code: FMF
• UDI-Device Identifier: 10884521546929
• UDI-Public: 10884521546929
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2021

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: 1181200777K
• Device Catalogue Number: 1181200777K
• Device Lot Number: 18F22
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/02/2021
• Supplement Date Received by Manufacturer: 04/02/2021
• Initial Report FDA Received Date: 04/27/2021
• Supplement Report FDA Received Date: 10/05/2021
• Patient Sequence Number: 1