MAUDE Adverse Event Report: COVIDIEN 6ML SYRINGE LUER LOCK TIP; SYRINGE, PISTON

Model Number	1180600777
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/02/2020
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 stated that they have excess bubbling when using the 6ml syringe to draw up blood.There was no patient harm.
Additional Manufacturer Narrative
The manufacturing site received sixteen (16) syringe assemblies for evaluation.A complete investigation was performed.Visual and physical inspection to the quality inspection standard, including leak testing, was conducted.No defects were identified relating to the reported condition were identified.The device history record (dhr) for the lot reported indicates that the product and specification requirements were met with no non-conforming product identified relating to this customer report.No issues were identified as a result of the current investigation including product analysis.Although the reported issue cannot be confirmed per the current investigation, due to the complaint trend, this information has been communicated to the appropriate production and engineering personnel for heightened awareness.Per the manufacturing site¿s procedure, complaint trends are evaluated during the monthly corrective and preventive action (capa) meeting to determine if a capa is warranted.At this time, there is not enough information and a capa will not be initiated.This complaint will be used for tracking and trending purposes.

• Brand Name: 6ML SYRINGE LUER LOCK TIP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 10174265
• Report Number: 1915484-2020-01172
• Device Sequence Number: 14048274
• Product Code: FMF
• UDI-Device Identifier: 10884521013582
• UDI-Public: 10884521013582
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2020

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: 1180600777
• Device Catalogue Number: 1180600777
• Device Lot Number: 935714X
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/03/2020
• Supplement Date Received by Manufacturer: 06/03/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 11/02/2020
• Patient Sequence Number: 1