MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD BIOSYN; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	M-74
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event was previously reported to the fda on a summary report and is now being submitted on a 3500a per fda request.Evaluation summary: post market vigilance (pmv) led an evaluation of received three devices.The visual inspection of the sample noted no suture and no needle.Visual inspection noted that the three foils was empty.The foil was inspected with light assisted microscopy with no abnormalities.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter: the distributor reported that only one suture was contained in the package.
Additional Manufacturer Narrative
Initial notification of this reportable event to fda.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter: the distributor reported that only one suture was contained in the package.

• Brand Name: BIOSYN
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 7316601
• Report Number: 9612501-2018-00309
• Device Sequence Number: 1455432
• Product Code: GAM
• UDI-Device Identifier: 10884521032972
• UDI-Public: 10884521032972
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2018

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: 07/31/2020
• Device Model Number: M-74
• Device Catalogue Number: M-74
• Device Lot Number: D5G2191X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2017
• Initial Date Received by Manufacturer: 03/21/2017
• Supplement Date Received by Manufacturer: 03/21/2017
• Initial Report FDA Received Date: 03/06/2018
• Supplement Report FDA Received Date: 03/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1