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

Model Number	CL-811
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/29/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during use, the needle detached from suture.No patient injury reported.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The event report alleges the product was used in a surgical procedure.Under magnification, instrument marks were observed at the swaged end of the needle.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Grasping the needle at the swaged end during application can damage the needle as observed.It is recommended that the needle be grasped from the needle body, where the wire is of a full diameter and significantly stronger than at the swaged end.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.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): COVIDIEN NORTH HAVEN - MFG; 195 mcdermott road; north haven CT 06473
• MDR Report Key: 6760938
• Report Number: 1219930-2017-06137
• Device Sequence Number: 1707605
• Product Code: GAM
• UDI-Device Identifier: 20884521041926
• UDI-Public: 20884521041926
• 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: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2017

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: 01/31/2022
• Device Model Number: CL-811
• Device Catalogue Number: CL-811
• Device Lot Number: A7A0623X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2017
• Initial Date Received by Manufacturer: 07/04/2017
• Supplement Date Received by Manufacturer: 08/09/2017
• Initial Report FDA Received Date: 08/02/2017
• Supplement Report FDA Received Date: 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1