MAUDE Adverse Event Report: TELEFLEX MEDICAL GREEN RUSCHLITE DISP MTL MAC 4; LARYNGOSCOPE, RIGID

Catalog Number 004551004

Device Problems Break (1069); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 06/05/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved in this complaint has not been received by the manufacturer at the time of this report.The investigation into this complaint is still in progress.

Event Description

Customer complaint received via medwatch# (b)(4), alleges the mac 4 blade was found broken in packaging in an intubation box.

Manufacturer Narrative

(b)(4).Med watch reference number: (b)(4).The sample was not returned for evaluation; therefore, the complaint could not be confirmed.If the sample is returned, a follow-up report will be submitted with investigation results.

Event Description

Customer complaint received via medwatch# (b)(4), alleges the mac 4 blade was found broken in packaging in an intubation box.

• Brand Name: GREEN RUSCHLITE DISP MTL MAC 4
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): TRUPHATEK INTERNATIONAL LTD.; 14 benny gaon street; p.o. 8051; netanya 42504 43; IS 4250443
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6692371
• MDR Text Key: 79269067
• Report Number: 8030121-2017-00098
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 06/16/2017

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: No Information
• Device Catalogue Number: 004551004
• Device Lot Number: 1608342
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/16/2017
• Initial Date FDA Received: 07/07/2017
• Supplement Dates Manufacturer Received: 08/07/2017
• Supplement Dates FDA Received: 08/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1