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

Model Number	GLJ-56-M
Medical Device Problem Codes	Manufacturing, Packaging or Shipping Problem (2975); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Radiation Exposure, Unintended (3164); No Code Available (3191)
Date of Event	10/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, after the surgery was completed, it was noticed that the number of needles was short by one.The tray containing the devices was checked, and it was possible that it contained only 4 needles from the start but they were unsure.It was reported that the nurse seemed not used to the procedure and she might have miscounted.An x ray was performed and nothing was found in the patient's cavity.The operating time extended by more than 30 min.The patient status was not listed.
Additional Manufacturer Narrative
Evaluation summary post market vigilance (pmv) led an evaluation of one device.The retainer was empty.Visual analysis of the returned product noted no abnormalities.A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.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.

• 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: 6993038
• Report Number: 9612501-2017-06519
• Device Sequence Number: 19155725
• Product Code: GAM
• UDI-Device Identifier: 10884521045583
• UDI-Public: 10884521045583
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K963253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2021
• Device Model Number: GLJ-56-M
• Device Catalogue Number: GLJ-56-M
• Device Lot Number: D6D2555X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2017
• Initial Date Received by Manufacturer: 10/11/2017
• Supplement Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 11/01/2017
• Supplement Report FDA Received Date: 03/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other