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

Model Number	88863385-56
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	04/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A quarterly summary report and is being resubmitted per fda request.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter: occurred during unpacking.One suture was missing.No known impact or consequence to patient.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted a missing pair of sutures and needles.Samples were forwarded to engineering for further evaluation of a missing pair of sutures and needles.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.However, an assembly error was identified during product analysis.The root cause of the observed condition of incorrect needle quantity was assigned to manpower.Due to the fact that personnel involved in the manufacturing process of this lot were properly trained and knew how to perform the task; however, they may have a lack of attention/application skipping the procedure step during the assembly process and inadvertently miss one unit prior to winding the sutures into the retainer.The product analysis established a relationship between a device failure and the reported incident of incorrect needle quantity.The root cause of the observed condition was determined to be a result of a manufacturing error and recertification and a corrective action have been implemented to prevent this condition from recurring.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: TI-CRON
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 6814120
• Report Number: 9612501-2017-06005
• Device Sequence Number: 16391804
• Product Code: GAT
• UDI-Device Identifier: 10884521062894
• UDI-Public: 10884521062894
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K930591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/28/2018

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: 03/31/2021
• Device Model Number: 88863385-56
• Device Catalogue Number: 88863385-56
• Device Lot Number: D6C1679X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2017
• Initial Date Received by Manufacturer: 04/12/2017
• Supplement Date Received by Manufacturer: 01/23/2018; 02/12/2018
• Initial Report FDA Received Date: 08/23/2017
• Supplement Report FDA Received Date: 02/08/2018; 02/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1