MAUDE Adverse Event Report: COVIDIEN NS-3631 N-STER DISPOSABLE; LITE GLOVE

Model Number 31159422

Device Problem Crack (1135)

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

Event Date 10/13/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: 11/18/2016.An investigation is currently underway.Upon completion, the results will be forwarded.Mansfield product monitoring has contacted the customer on 11/16/2016, 11/17/2016, and 11/18/2016.To date, no response has been received.If additional pertinent information becomes available, the report will be updated.

Event Description

It was reported to covidien on (b)(6) 2016 that an issue occurred with an enteral feeding pump.The customer reports two cracked light handle covers.

• Brand Name: NS-3631 N-STER DISPOSABLE
• 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: 6112843
• MDR Text Key: 60370588
• Report Number: 9612030-2016-00664
• Device Sequence Number: 1
• Product Code: LYU
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 31159422
• Device Catalogue Number: 31159422
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1