MAUDE Adverse Event Report: COVIDIEN 6CC SYR ONLY LUER LOCK TIP D/S; SYRINGE

Model Number 1180600777

Device Problems Air Leak (1008); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 10/31/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: 11/28/2016.An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with a syringe.The customer reports that the clinicians have experienced bubbling problems with the 6ml syringes.When they pull back on the syringe, air enters into the syringe and causes bubbling.

• Brand Name: 6CC SYR ONLY LUER LOCK TIP D/S
• 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 street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6129002
• MDR Text Key: 61234775
• Report Number: 1915484-2016-00076
• Device Sequence Number: 1
• Product Code: FMF
• 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: 11/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1180600777
• Device Catalogue Number: 1180600777
• Device Lot Number: 6152440
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/03/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1