MAUDE Adverse Event Report: COVIDIEN 60ML LUER LOCK PHARMACY TRAY; SYRINGE, PISTON

Model Number	8881560232
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reports that the tip of the 60 ml syringe is breaking off rendering the syringe useless.No patient harm.Additional information stated that the syringes are also leaking when this occurs.

• Brand Name: 60ML LUER LOCK PHARMACY TRAY
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 10313417
• Report Number: 9612030-2020-02540
• Device Sequence Number: 11619731
• Product Code: FMF
• UDI-Device Identifier: 10884521012271
• UDI-Public: 10884521012271
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/23/2020

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: 8881560232
• Device Catalogue Number: 8881560232
• Device Lot Number: 2001420564
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 07/23/2020
• Patient Sequence Number: 1