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

Model Number	VP-726-X
Medical Device Problem Codes	Detachment Of Device Component (1104); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter: during an open procedure for polytetrafluoroethylene (ptfe) prosthesis construction and vein anastomosis, the needle detached from the suture.The needle fell into the patient's cavity.Prior to use the suture was treated/hydrated with saline.Replaced by a new device to complete the case.

• Brand Name: SURGIPRO LL
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 7601520
• Report Number: 9612501-2018-01103
• Device Sequence Number: 2129561
• Product Code: GAW
• UDI-Device Identifier: 20884521038681
• UDI-Public: 20884521038681
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K050947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/14/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: VP-726-X
• Device Catalogue Number: VP-726-X
• Device Lot Number: D7F1920SX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 06/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1