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

Model Number	GL-127
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Radiation Exposure, Unintended (3164); No Code Available (3191)
Date of Event	09/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during the subcutaneous closure of a caesarean section, the needle separated into 2 parts, the thread with a needle tip on one side, and the rest of the needle on the other side in the patient.After 10 minutes of searching under gloss, the needle was taken out of the abdominal wall of the patient.The patient underwent an unplanned radiological examination.Another suture was used to complete the case.The surgical time was extended by 52 minutes as a result of the event.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led a photographic evaluation of one image of a device.Photographic inspection noted a suture and a needle separated.Photographic inspection noted that the needle was broken, bent and the swage was separated.The swage was attached to the suture.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.A definitive root cause could not be determined with regard to the reported condition.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 mcdermott rd; north haven CT 06473
• MDR Report Key: 9161898
• Report Number: 1219930-2019-05611
• Device Sequence Number: 13958091
• Product Code: GAM
• UDI-Device Identifier: 10884521045019
• UDI-Public: 10884521045019
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K963253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2019

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: 05/31/2023
• Device Model Number: GL-127
• Device Catalogue Number: GL-127
• Device Lot Number: A8E0162X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/13/2019
• Supplement Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 10/07/2019
• Supplement Report FDA Received Date: 11/04/2019
• 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: Required Intervention