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

Model Number S931BX

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

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 an open procedure, the needle popped off.Another suture was used to complete the procedure.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 18750 ; DO 18750
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 18750 ; DO 18750
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 9102223
• MDR Text Key: 164167630
• Report Number: 9612501-2019-01790
• Device Sequence Number: 1
• Product Code: GAR
• UDI-Device Identifier: 10612479213279
• UDI-Public: 10612479213279
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: S931BX
• Device Catalogue Number: S931BX
• Device Lot Number: D8B1522FX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/27/2019
• Date Device Manufactured: 02/15/2018
• 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