MAUDE Adverse Event Report: TELEFLEX MEDICAL OEM UNKNOWN DUMMY MATERIAL

Catalog Number OEM UNKNOWN

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 12/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation at this time.The manufacturer will continue to monitor and trend related events.

Event Description

The bullet broke during a procedure.The patient's condition was reported as unknown.

Manufacturer Narrative

(b)(4).A dhr review could not be conducted since the lot number was not provided.A failure mode duplication could not be conducted at this time, due to the complaint stating an interaction with capio device, which is a device from customer (boston scientific) and not from teleflex plant.No corrective actions can be implemented due the lack of product sample and batch number to perform a proper investigation and determine the root cause.Customer complaint cannot be confirmed due the lack of product sample and batch number to perform a proper investigation and determine the root cause.

Event Description

The bullet broke during a procedure.The patient's condition was reported as unknown.

• Brand Name: OEM UNKNOWN DUMMY MATERIAL
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 6169038
• MDR Text Key: 62609127
• Report Number: 3004365956-2016-00458
• Device Sequence Number: 1
• Product Code: BSJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: OEM UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2016
• 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: N
• Patient Sequence Number: 1