MAUDE Adverse Event Report: PURITAN MEDICAL PRODUCTS; KIT VITRECTOMY WESTCHESTER

Catalog Number	DYNJ905372
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during an unidentified procedure the puritan medical products cotton tip applicator linted into the patient's eyes.After multiple good-faith attempts, the facility was unable or unwilling to provide additional patient, product, or procedural information to the pack manufacturer.It is unknown how the cotton tip applicator was being used at the time of the incident and how the linted material was removed from the patient's eyes.No impact or adverse effect to the patient, the patient's stability, or the patient's plan of care reported.Samples of cotton-tipped applicators were returned to the pack manufacturer.The cotton tip was noted to be loose on some of the applicators.No lot information was originally reported to the pack manufacturer.It is unknown if the samples were from the same lot as the cotton tip applicator used during the unidentified procedure.A root cause for the reported incident could not be determined.Puritan medical products will be notified of the reported incident by the pack manufacturer.Due to the reported incident, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that during an unidentified procedure the puritan medical products cotton tip applicator linted into the patient's eyes.

• Common Device Name: KIT VITRECTOMY WESTCHESTER
• Manufacturer (Section D): PURITAN MEDICAL PRODUCTS; 31 school street; guilford ME 04443 0149
• MDR Report Key: 8160876
• Report Number: 1423395-2018-00061
• Device Sequence Number: 2070320
• Product Code: LRO
• UDI-Device Identifier: 10889942906321
• UDI-Public: 10889942906321
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/13/2018

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 Catalogue Number: DYNJ905372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 12/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other