MAUDE Adverse Event Report: TELEFLEX MEDICAL HOOK PROBE

Catalog Number ECMH300

Device Problem Melted (1385)

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

Event Date 03/07/2015

Event Type  malfunction  

Event Description

Alleged event: the needle tip, the plastic melted.The patient outcome was reported as no impact.

Manufacturer Narrative

(b)(4).The device sample has been returned to the mfr for investigation but the investigation report has not been submitted at the time of this report.The mfr will continue to monitor and trend related events.

• Brand Name: HOOK PROBE
• Type of Device: NI
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 2917 weck dr.; research triangle park NC 27709
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 4801670
• MDR Text Key: 5915940
• Report Number: 1044475-2015-00166
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ECMH300
• Other Device ID Number: 20013106
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/08/2015
• Date Manufacturer Received: 05/01/2015
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1