MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SURGIPRO II; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLEN

Model Number VP706MX-2

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 04/11/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter prior to use, the suture pack has missing a strand.There should be ten needles, instead there are only eight.A double armed strand of suture is missing from the package.There was no patient involvement.

• Brand Name: SURGIPRO II
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLEN
• 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: 14215480
• MDR Text Key: 290154315
• Report Number: 9612501-2022-00676
• Device Sequence Number: 1
• Product Code: GAW
• UDI-Device Identifier: 10884521758322
• UDI-Public: 10884521758322
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954808
• 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: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VP706MX-2
• Device Catalogue Number: VP706MX-2
• Device Lot Number: D1D0331Y
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/11/2022
• Date Device Manufactured: 04/10/2021
• 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