MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN V-LOC 90; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	VLOCM0123
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/20/2017
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: occurred during an open section procedure.The suture was being used for the skin closure.The loop of the suture has gone up.The thread of the suture broke.Occurred one minute into the procedure.The suture was removed from the packaging two minutes before use.In order to resolve the issue and complete the case, an additional new suture was used without issue.There was no patient harm.The patient outcome is alive, no 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, as per the additional information received, loop for fixation has gone up(the bond has not kept from the loop).The device could not be used.
Additional Manufacturer Narrative
Investigation summary post market vigilance (pmv) led an evaluation of the packaging of one device.The returned packaging was visually inspected with acceptable results.A review of the device history record for the product indicates the following non-conformances were noted which are related to the reported condition: ncr 17070536.An incomplete weld was found during the retaining process.The entire lot was visually inspected to remove any other bad parts.No other parts were found and the lot was processed as usual.It is unlikely that the reported condition was related to the ncr.Since a product sample was not returned for investigation, we are not able to identify a root cause or speculate on a probable root cause.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: V-LOC 90
• 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: 7037113
• Report Number: 1219930-2017-08820
• Device Sequence Number: 1239117
• Product Code: GAM
• UDI-Device Identifier: 20884521132235
• UDI-Public: 20884521132235
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/06/2018

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: 07/31/2020
• Device Model Number: VLOCM0123
• Device Catalogue Number: VLOCM0123
• Device Lot Number: A7G0346VFX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2017
• Initial Date Received by Manufacturer: 10/23/2017
• Supplement Date Received by Manufacturer: 11/13/2017; 02/28/2018; 03/21/2018
• Initial Report FDA Received Date: 11/16/2017
• Supplement Report FDA Received Date: 12/12/2017; 03/16/2018; 04/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1