MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN SURGIPRO II; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	VP-744-MX
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/14/2017
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 there was only one suture in the package and there should have been two.No patient involvement.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of device opened by account.Visual inspection of the sample noted that the sample contained only two needles, the correct quantity for this product is four needles.No additional abnormalities were noted.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 error was identified during product analysis resulting from incorrect execution of the assembly process.Retaining of this product is a manual process.In this instance, a suture was not included in the package due to an error by the assembler.Awareness training for this defect had been completed.Since this product was manufactured prior to that awareness training, the same awareness training will be adequate to encompass this complaint as well.Awareness training is attached.The product analysis established a relationship between a device failure and the reported incident of incorrect quantity.A cross functional team has reviewed the risk and rate of occurrence for this failure mode and complaint mode and has determined that no corrective actions are warranted at this time.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: SURGIPRO II
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mc dermott rd; north haven CT 06473
• MDR Report Key: 6700892
• Report Number: 1219930-2017-05977
• Device Sequence Number: 19348995
• Product Code: GAW
• UDI-Device Identifier: 20884521038889
• UDI-Public: 20884521038889
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2018

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: 01/31/2022
• Device Model Number: VP-744-MX
• Device Catalogue Number: VP-744-MX
• Device Lot Number: A7A0055X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2017
• Initial Date Received by Manufacturer: 06/15/2017
• Supplement Date Received by Manufacturer: 12/13/2017
• Initial Report FDA Received Date: 07/11/2017
• Supplement Report FDA Received Date: 01/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1