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

Model Number	CL-271
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/08/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during an open liver resection procedure, the needle was blunt and caused bleeding.The customer is requesting the device analysis to understand the reason of the liver bleeding.The device must be blind-point not to cause the bleeding.Bleeding inhibitor was used to stop the bleeding and the case was completed with the same device without any complication.No surgical intervention was required and bleeding was not more than 500 cc's.Patient status is alive no injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual and dimensional analysis concluded that the suture was within 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.Analysis concluded there were no assembly component related failures; additionally, a review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.The reported condition of blunt needle was confirmed, as the label indicates that the needle contained was a blunt pointed needle, the correct product was found to be contained within the packaging, and the needle was within specifications for this product.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: 6695591
• Report Number: 9612501-2017-05741
• Device Sequence Number: 19025676
• Product Code: GAM
• UDI-Device Identifier: 10884521040458
• UDI-Public: 10884521040458
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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,Followup
• Report Date (Section B): 10/19/2017

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: 02/28/2021
• Device Model Number: CL-271
• Device Catalogue Number: CL-271
• Device Lot Number: D6B1567X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2017
• Initial Date Received by Manufacturer: 06/11/2017
• Supplement Date Received by Manufacturer: 08/02/2017; 09/25/2017
• Initial Report FDA Received Date: 07/07/2017
• Supplement Report FDA Received Date: 08/30/2017; 10/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1