MAUDE Adverse Event Report: COVIDIEN 60CC SYRINGE ONLY LUER LOCK TIP

Model Number 8881560125

Device Problem Bent (1059)

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

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently under way; upon completion the results will be forwarded.

Event Description

It was reported to covidien (b)(6) 2016 that a customer had an issue with a syringe.Customer had reported issues with bent tips however the investigation found that a syringe had a plunger that did not seal with the barrel of the syringe.

• Brand Name: 60CC SYRINGE ONLY LUER LOCK TIP
• Type of Device: SYRINGE
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd.; norfolk NE 68701
• Manufacturer (Section G): COVIDIEN; 1222 sherwood rd.; norfolk NE 68701
• Manufacturer Contact: edward almeida ; 15 hampshire st.; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6002503
• MDR Text Key: 57074060
• Report Number: 1915484-2016-00064
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8881560125
• Device Catalogue Number: 8881560125
• Device Lot Number: 601428X
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/09/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1