MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD STEEL; SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE

Model Number 88862393-69

Device Problems Dull, Blunt (2407); Material Twisted/Bent (2981)

Patient Problems Hemorrhage/Bleeding (1888); Insufficient Information (4580)

Event Date 01/22/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, intra-operatively, the wire did not go through the sternum well.Needles bent and needed to be passed multiple times for a simple wire resulting in increased bleeding and more time spent on putting in the wires.

• Brand Name: STEEL
• Type of Device: SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 11618873
• MDR Text Key: 243926938
• Report Number: 9612501-2021-00546
• Device Sequence Number: 1
• Product Code: GAQ
• UDI-Device Identifier: 10884521102477
• UDI-Public: 10884521102477
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K955723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/06/2021

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: Health Professional
• Device Model Number: 88862393-69
• Device Catalogue Number: 88862393-69
• Device Lot Number: D0H1746Y
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/15/2021
• Initial Date FDA Received: 04/06/2021
• Date Device Manufactured: 08/15/2020
• 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