MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD BLUNTPORT PLUS; GOUGE, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	179775P
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/28/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, prior to use, the nurse found rubber packing in the grip disengaged.The device was not used on the patient.The procedure was completed with another device.

• Brand Name: BLUNTPORT PLUS
• Common Device Name: GOUGE, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 6525605
• Report Number: 9612501-2017-05395
• Device Sequence Number: 885473
• Product Code: GDH
• UDI-Device Identifier: 10884521081161
• UDI-Public: 10884521081161
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K903419
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/28/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: 179775P
• Device Catalogue Number: 179775P
• Device Lot Number: J6H2004X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2017
• Initial Report FDA Received Date: 04/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1