MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD MCKESSON; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Model Number S699GX

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/14/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, during right index finger laceration repair, the needle was secured using needle driver and introduced to wound edge.Needle driver was able to loop the needle through wound up to the opposite side, however the base of the needle broke approximately 2mm from nylon suture.Another suture was opened to complete the case.There was no patient injury.

• Brand Name: MCKESSON
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• 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: 11966091
• MDR Text Key: 255387187
• Report Number: 9612501-2021-00947
• Device Sequence Number: 1
• Product Code: GAR
• UDI-Device Identifier: 20612479214532
• UDI-Public: 20612479214532
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K900531
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/09/2021

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: S699GX
• Device Catalogue Number: S699GX
• Device Lot Number: D0L1088FY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2021
• Initial Date FDA Received: 06/09/2021
• Date Device Manufactured: 11/10/2020
• 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