MAUDE Adverse Event Report: COVIDIEN 3ML SYRINGE LUER LOCK TIP; SYRINGE, PISTON

Model Number	1180300777
Medical Device Problem Codes	Material Fragmentation (1261); Missing Information (4053)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation because it was discarded 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 the annotation on the syringes was peeling off and can no longer be used on the sterile field.Additional information received on 12-nov-2019 stated that both the text and the graduation marks were peeling off the syringe and transferred to the entire field and also the saline bowl and into the syringes themselves.There were missing graduation marks.It was discovered about 1.5 hours into the case.

• Brand Name: 3ML SYRINGE LUER LOCK TIP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 9312477
• Report Number: 1017768-2019-00732
• Device Sequence Number: 437804
• Product Code: FMF
• UDI-Device Identifier: 10884521012301
• UDI-Public: 10884521012301
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 11/12/2019

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: 1180300777
• Device Catalogue Number: 1180300777
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 11/12/2019
• Patient Sequence Number: 1