MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SOFSILK; SUTURE, NONABSORBABLE, SILK

Model Number	GSJ-34-M
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	12/05/2019
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, prior to use, there were six products inside one packet, so it caused trouble in counting the needle.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of ten devices.Visual inspection of the opened samples noted seven retainer, six breathable pouches and thirty-six suture-needles.All of the retainer had five needles/sutures winded inside, these were properly parked in the foam of the retainer.A suture/needle was received parked in a pink foam provided by the account.Visual inspection of the products received sealed noted five suture/needles in each 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.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, prior to use, there were six products inside one packet and caused trouble in counting the needle.The needles from the defective packet were retrieved and a new product was opened.

• Brand Name: SOFSILK
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 18750 ; DO 18750
• MDR Report Key: 9485315
• Report Number: 9612501-2019-02465
• Device Sequence Number: 399183
• Product Code: GAP
• UDI-Device Identifier: 20884521085319
• UDI-Public: 20884521085319
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K981128
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2020

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: 05/31/2024
• Device Model Number: GSJ-34-M
• Device Catalogue Number: GSJ-34-M
• Device Lot Number: D9F2024Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2019
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 02/07/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 02/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1