MAUDE Adverse Event Report: COVIDIEN TB SAFETY SYRINGE 1CC 28G X1/2IN

Model Number 8881511201

Device Problem Physical Resistance (2578)

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 on (b)(6) 2017 that a customer had an issue with a safety syringe.The customer states that the medicine is difficult to draw into the syringe and will not stay in the syringe.Additional information was requested with no response to date.

• Brand Name: TB SAFETY SYRINGE 1CC 28G X1/2IN
• Type of Device: SAFETY 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: 6289366
• MDR Text Key: 66445475
• Report Number: 1915484-2017-00011
• 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,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/06/2017

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: Health Professional
• Device Model Number: 8881511201
• Device Catalogue Number: 8881511201
• Device Lot Number: 623826X
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/06/2017
• Initial Date FDA Received: 01/31/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1