MAUDE Adverse Event Report: COVIDIEN 12ML SYRINGE LUER LOCK TIP; SYRINGE, PISTON

Model Number	1181200777
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that they had difficulty attaching the 12ml syringes to the braun #490402 extension set.
Additional Manufacturer Narrative
A device history record could not be reviewed because a lot number could not be provided by the customer.A product analysis was unable to be completed as to date no samples or pictures have been provided.Precluding any further information or evidence there is not enough information at this time to determine with any confidence what likely caused the reported issue.Potential root causes for the issue are: mold damage, misaligned threading or issues with the port on the braun #490402 ext.Set.If additional information or evidence becomes available, the complaint will be reopened and the root cause reassessed.This issue has been determined to be an isolated event.The product should be inspected prior to use for any damage.Based on existing controls, and the complaint history, neither corrective nor preventive actions are warranted at this time.

• Brand Name: 12ML SYRINGE LUER LOCK TIP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 9818525
• Report Number: 1424643-2020-00572
• Device Sequence Number: 19604730
• Product Code: FMF
• UDI-Device Identifier: 10884521010000
• UDI-Public: 10884521010000
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 04/24/2020

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: 1181200777
• Device Catalogue Number: 1181200777
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 03/11/2020
• Supplement Report FDA Received Date: 04/24/2020
• Patient Sequence Number: 1