MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN POLYSORB; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	GL-303
Medical Device Problem Codes	Component Missing (2306); Packaging Problem (3007)
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, the product's needle was not in the needle holder as it should be.The needle could not be taken out immediately it was hidden in a plastic enclosure.To take the needle out, one has to open the plastic enclosure.Accordingly, it was disturbing for a complicated surgery.Patient involvement was unknown.
Additional Manufacturer Narrative
Based on review of the file, this report was updated from a malfunction to a non-reportable event.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Analysis summary: post market vigilance (pmv) received twenty-eight devices.The visual inspection of the returned products noted twenty-eight sealed products.A tactile and microscopic inspection of the sutures was performed with no abnormalities.The retainers were inspected and the needle was parked improperly in some retainers.Send to engineering for improperly parked needles.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 twenty-eight device.The visual inspection of the returned products noted twenty-eight sealed products.A tactile and microscopic inspection of the sutures was performed with no abnormalities.The retainers were inspected and the needle was parked improperly in seven out of the twenty-eight retainers.Engineer concluded that since there are no records of any issues with the vision system during the packaging of this lot, the needles shifted after it left the form, fill, and seal machine.A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.The root cause of the inaccessible needles cannot be reliably determined considering vision systems are in place to prevent this issue and there is no indication that they were not functioning properly during the manufacturing of this lot.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.
Additional Manufacturer Narrative
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): COVIDIEN LP LLC NORTH HAVEN; 195 mc dermott rd; north haven CT 06473
• MDR Report Key: 6900239
• Report Number: 1219930-2017-07482
• Device Sequence Number: 16416510
• Product Code: GAM
• UDI-Device Identifier: 20884521045221
• UDI-Public: 20884521045221
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/27/2018

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: 12/31/2021
• Device Model Number: GL-303
• Device Catalogue Number: GL-303
• Device Lot Number: A6M0526X
• 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: 09/07/2017; 12/15/2017; 01/23/2018; 04/19/2018
• Initial Report FDA Received Date: 09/28/2017
• Supplement Report FDA Received Date: 10/18/2017; 01/09/2018; 01/26/2018; 04/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1