MAUDE Adverse Event Report: PDI/NICE-PAK PRODUCTS, INC. PREVANTICS; SWAB STICK IN DRESSING CHANGE TRAY

Catalog Number	DYNDC2395A
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was initially reported that during skin prep, staff noted "fuzz particles" coming off the swab stick (taken from dressing change try).Per report, these particles had imbedded into the patient's skin and were not able to be removed.Despite good faith efforts to obtain additional information, no further patient, product, procedural, or event details are available.Due to the reported issue and in an abundance of caution, this medwatch is being filed.A sample has not been returned for evaluation.The manufacturer of the swab stick has been notified of this incident.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that "fuzz particles" were coming off the swab stick (taken from dressing change tray).Per report, the fuzz particles had imbedded down into the skin and were not able to be removed.
Additional Manufacturer Narrative
Additional information was received from the reporting facility.Per report, the patient reportedly has a hickman catheter and "fuzz (from swabstick) is still stuck to his line, we have tried to remove what we can without causing him pain or pulling at the line, but this is an infection risk." no additional information was reported.A sample has not been returned for evaluation.The manufacturer of the swab stick has been notified of this incident.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.

• Brand Name: PREVANTICS
• Common Device Name: SWAB STICK IN DRESSING CHANGE TRAY
• Manufacturer (Section D): PDI/NICE-PAK PRODUCTS, INC.; 400 chestnut ridge road; woodcliff lake NJ 07677
• MDR Report Key: 8960014
• Report Number: 1417592-2019-00154
• Device Sequence Number: 2584870
• Product Code: MCY
• UDI-Device Identifier: 10889942781843
• UDI-Public: 10889942781843
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYNDC2395A
• Device Lot Number: 18FBR284
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 09/04/2019
• Supplement Report FDA Received Date: 09/20/2019
• 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