MAUDE Adverse Event Report: COVIDIEN 12ML SYRINGE REGULAR LUER RP; SYRINGE, PISTON

Model Number	8881512852
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/02/2020
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 they went to transfer blood from the syringe using a blood transfer device and the tip of the syringe broke during the transfer.
Additional Manufacturer Narrative
A review of the device history record revealed no discrepancies that may have contributed to the reported condition.A photograph was provided by the customer and was evaluated.In the photograph the reported condition is observed with an oblique fracture originating near the base of the luer tip.It cannot be confirmed if the sample met original specifications before use.No other damage or issues are observed in the photograph.The oblique fracture suggests that a force was applied perpendicular to the axis of the luer tip which caused the breakage.The amount of force applied is unknown and the cause of force is unknown.The method of root cause analysis implemented in this investigation was to conduct a six m assessment that evaluated potential causes.In the event where a deficiency originated during manufacturing, the most probable root cause of the reported condition is likely a mechanical jam occurring in the transport system which was not properly removed from the process.

• Brand Name: 12ML SYRINGE REGULAR LUER RP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 10049468
• Report Number: 1424643-2020-00576
• Device Sequence Number: 2848448
• Product Code: FMF
• UDI-Device Identifier: 20884521012070
• UDI-Public: 20884521012070
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2020

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: 8881512852
• Device Catalogue Number: 8881512852
• Device Lot Number: 18K12063X
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/21/2020
• Supplement Date Received by Manufacturer: 04/21/2020
• Initial Report FDA Received Date: 05/12/2020
• Supplement Report FDA Received Date: 05/21/2020
• Patient Sequence Number: 1