MAUDE Adverse Event Report: COVIDIEN 20CC LUER LOCK PHARMACY TRAY 25S; SYRINGE

Model Number 8881520251

Device Problems Particulates (1451); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 01/12/2016.An investigation is currently under way; upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2015 that a customer had an issue with a syringe.Customer reports that syringes have white particulate in the syringe.Possibly plastic from the syringe barrel or plunger and appears to be free-floating plastic shavings.The device will be returned for evaluation.

• Brand Name: 20CC LUER LOCK PHARMACY TRAY 25S
• Type of Device: SYRINGE
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad; industrial; tijuana ; MX
• Manufacturer (Section G): COVIDIEN; calle 9 sur no. 125 cuidad; industrial; tijuana ; MX
• Manufacturer Contact: thom mcnamara ; 15 hampshire st; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5360680
• MDR Text Key: 36083902
• Report Number: 9612030-2016-00008
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8881520251
• Device Catalogue Number: 8881520251
• Device Lot Number: 515382064X
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/16/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1