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

Model Number	GLS-123
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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, one envelope was empty and had no suture and needle.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The foil pouch was received without a retainer.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 / component error was identified during product analysis.The root cause of the observed damage was an assembly error.Replication of this condition may occur if the packaging operator does not perform a 100% visual inspection to assure the unit is defect free.The product analysis established a relationship between a device failure and the reported incident of retainer missing from foil.The root cause of the observed condition was determined to be a result of a manufacturing activity and a process improvement has 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.

• Brand Name: POLYSORB
• 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: 6900222
• Report Number: 9612501-2017-06275
• Device Sequence Number: 13611575
• Product Code: GAM
• UDI-Device Identifier: 10884521045637
• UDI-Public: 10884521045637
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K963253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2018

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: 09/30/2021
• Device Model Number: GLS-123
• Device Catalogue Number: GLS-123
• Device Lot Number: D6J2925X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2017
• Initial Date Received by Manufacturer: 09/07/2017
• Supplement Date Received by Manufacturer: 01/02/2018
• Initial Report FDA Received Date: 09/28/2017
• Supplement Report FDA Received Date: 01/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1