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

Model Number	CL-892
Medical Device Problem Codes	Break (1069); Difficult to Open or Remove Packaging Material (2922); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/29/2017
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 needle broke during a cesarean section.No patient injury reported.
Additional Manufacturer Narrative
This product event is not reportable.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.
Additional Manufacturer Narrative
Investigation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the products noted that the needle wasn't parked in the correct cavity of the retainer.The needle was observed to be inaccessible in the retainer which made the suture removal from retainer difficult.Samples were sent to engineering for further evaluation of improperly parked needle/suture remover from retainer difficult.Engineer concluded that the inaccessible needles can be attributed to rough handling during the assembly process.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 inaccessible needles in the retainer was determined to be that the needle shifted after it left the form, fill, and seal machine.The foam in the retainer aims to prevent the needle from shifting due to handling during the assembly process or shipping and handling after the product leaves our facility.However, excessive handling can cause the needle to shift from its properly parked position.The root cause of the observed condition was determined to be a result of a manufacturing error.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): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven 06473
• MDR Report Key: 6756772
• Report Number: 1219930-2017-06114
• Device Sequence Number: 854908
• Product Code: GAM
• UDI-Device Identifier: 10884521042810
• UDI-Public: 10884521042810
• 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,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/24/2018

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: 05/31/2021
• Device Model Number: CL-892
• Device Catalogue Number: CL-892
• Device Lot Number: A6E0237X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2017
• Initial Date Received by Manufacturer: 07/03/2017
• Supplement Date Received by Manufacturer: 07/17/2017; 01/11/2018; 02/08/2018
• Initial Report FDA Received Date: 08/01/2017
• Supplement Report FDA Received Date: 08/08/2017; 01/29/2018; 02/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1