MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD NOVAFIL; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	SPB-5143G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/21/2019
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 a skin closure procedure for a wound, at the 1st stitch the needle and thread of the device broke.There was no patient injury.

• Brand Name: NOVAFIL
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 18750 ; DO 18750
• MDR Report Key: 8775944
• Report Number: 9612501-2019-01346
• Device Sequence Number: 1978025
• Product Code: GAT
• UDI-Device Identifier: 20884521100814
• UDI-Public: 20884521100814
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K990952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/10/2019

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: 05/31/2022
• Device Model Number: SPB-5143G
• Device Catalogue Number: SPB-5143G
• Device Lot Number: D7E0059X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 07/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1