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

Model Number 8881560232

Device Problem Material Separation (1562)

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

Event Date 10/09/2020

Event Type  malfunction  

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.

Event Description

Customer reports: the tips on the syringes are breaking off after capped, therefore, making the medicine inside not usable.

• Brand Name: 60ML LUER LOCK PHARMACY TRAY
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• Manufacturer (Section G): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 10667001
• MDR Text Key: 211021621
• Report Number: 1915484-2020-01195
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00884521012271
• UDI-Public: 0884521012271
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/12/2020

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
• Device Operator: No Information
• Device Model Number: 8881560232
• Device Catalogue Number: 8881560232
• Initial Date Manufacturer Received: 10/09/2020
• Initial Date FDA Received: 10/12/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1