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

Model Number	SP-675
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/29/2019
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 an open bypass procedure, while skin suturing, the needle separated from the strand after taking the suture from the package.It happened about 10 times with the same suture and same procedure.The another suture from the same package was taken to complete the procedure.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary post market vigilance (pmv) led an evaluation of two devices.Visual inspection of the opened product returned noted one suture one needle detached.Microscopic inspection of the needle swage noted proper crimp marks.Visual inspection of the sealed sample noted one suture and one needle attached.The sealed sample is a representative sample to this complaint.A tactile and microscopic inspection of the suture was performed with no abnormalities.A tensile test was performed on the sealed sample and the results met the specifications for this product.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Based on the evidence available the reported condition was confirmed.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURGIPRO
• 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: 8625707
• Report Number: 9612501-2019-00989
• Device Sequence Number: 2232645
• Product Code: GAW
• UDI-Device Identifier: 10884521037441
• UDI-Public: 10884521037441
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K954808
• 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,Followup
• Report Date (Section B): 06/24/2019

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: 07/31/2022
• Device Model Number: SP-675
• Device Catalogue Number: SP-675
• Device Lot Number: D7G1897FPX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Initial Date Received by Manufacturer: 04/29/2019
• Supplement Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 05/20/2019
• Supplement Report FDA Received Date: 06/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1