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

Model Number 88862224-69

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

According to the reporter, intra-operatively, the needle broke from the steel suture.

Manufacturer Narrative

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

• Brand Name: STEEL
• Type of Device: SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND
• 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: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 12817695
• MDR Text Key: 280880445
• Report Number: 9612501-2021-01878
• Device Sequence Number: 1
• Product Code: GAQ
• UDI-Device Identifier: 10884521102361
• UDI-Public: 10884521102361
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K955723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 88862224-69
• Device Catalogue Number: 88862224-69
• Device Lot Number: D0M0401Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2021
• Date Device Manufactured: 02/16/2018
• 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