MAUDE Adverse Event Report: COVIDIEN 3612 LITE GLOVE

Model Number 31140257

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 1/19/2017.An investigation is currently under way; upon completion the results will be forwarded.

Event Description

It was reported to covidien on 1/19/2017 that a customer had an issue with a syringe.The customer states that the lite gloves tears at pulling over handle.No patient present.

• Brand Name: 3612 LITE GLOVE
• Type of Device: LITE GLOVE
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad; industrial; tijuana ; MX
• Manufacturer (Section G): COVIDIEN; calle 9 sur no. 125 cuidad; industrial; tijuana ; MX
• Manufacturer Contact: edward almeida ; 15 hampshire st.; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6305721
• MDR Text Key: 66864591
• Report Number: 9612030-2017-00058
• Device Sequence Number: 1
• Product Code: LYU
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 31140257
• Device Catalogue Number: 31140257
• Device Lot Number: 6158100264
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/19/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1