MAUDE Adverse Event Report: COVIDIEN NEEDLES + SYRINGES UNK; INSULIN SYRINGE

Model Number UNK NS

Device Problem Air Leak (1008)

Patient Problem Reaction (2414)

Event Type  Other  

Event Description

It was reported to covidien on (b)(6) 2014 that a customer had an issue with an insulin syringe.The customer reports an issue with a monoject ultra-comfort, 28 gauge, 1/2 ml.The customer reports every time the product is used, there is trouble with getting air bubbles.The customer states sometimes it is not just an air bubble, but a vacuum lock.The customer reports this is not always visually detectable, but once he starts injecting, he can feel the difference.This creates not just the danger of air, but danger of misdosing.The customer states he can never be certain how much insulin, if any, was received with the vacuum.The customer states if he guesses incorrectly, there is a danger of either very high blood sugars or insulin reactions, which the blood sugars or insulin reactions, which the customer reports he has suffered as a result of this.

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

• Brand Name: NEEDLES + SYRINGES UNK
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd.; norfolk NE 68701
• Manufacturer (Section G): COVIDIEN; 1222 sherwood rd.; norfolk NE 68701
• Manufacturer Contact: elaine bishop ; 15 hampshire st; mansfield, MA 02048 ; 5084524686
• MDR Report Key: 3698750
• MDR Text Key: 4262750
• Report Number: 1915484-2014-00007
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Type of Report: Initial
• Report Date: 03/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNK NS
• Device Catalogue Number: UNK NS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1