MAUDE Adverse Event Report: COVIDIEN TICRON 2 BLUE 5X30 DT-25/KV-37; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	8886314783
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
According to the reporter, the box received had 4 needles instead of 5.No patient involvement.To correct this, they used a new pack.
Additional Manufacturer Narrative
(b)(4).It was confirmed by the account that the device was not used on the patient and there was no patient injury.
Additional Manufacturer Narrative
(b)(4).Post market vigilance (pmv) led an evaluation of one device opened and returned by the account.This evaluation was based on a technical review of all data received from the site, a pmv review of manufacturing records, a pmv review of complaint trends, and an evaluation of the returned sample.Visual inspection of the returned sample noted four needles and four sutures.Since the sample was received open, the root cause of the reported condition could not be reliably determined.Should new information become available, the file will be re-opened and reassessed at that time.

• Brand Name: TICRON 2 BLUE 5X30 DT-25/KV-37
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• MDR Report Key: 6003980
• Report Number: 9612501-2016-00717
• Device Sequence Number: 671219
• Product Code: GAT
• UDI-Device Identifier: 00884521060343
• UDI-Public: (01)00884521060343(17)210331(10)
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K930591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/14/2016

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: 03/31/2021
• Device Model Number: 8886314783
• Device Catalogue Number: 8886314783
• Device Lot Number: D6C1693X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/14/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/06/2016
• Supplement Report FDA Received Date: 10/31/2016; 12/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1