MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; GAUZE,SPONGE,4X4,8PLY,NS,LF,200/PK

Catalog Number	PRM21408CZ
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the gauze sponges tear easily and this left small pieces of lint onto patients' wounds.No information was provided about the type and location of the wounds.Reportedly, linting was not identified during inspection of the gauze sponges prior to use.It was denied that the gauze sponges were unfolded beyond the first fold.After noting lint on the patients' wounds, it was reported that irrigation with normal saline and light debridement was required.The patients are reportedly doing well at this time.There was no serious injury reported related to this event.Due to the reported linting onto the patients' wounds and the required irrigation and light debridement, this medwatch is being filed.Samples were not returned for evaluation.A definitive root cause for the reported issue could not be determined at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that small pieces of lint from gauze sponges reached patients' wounds, which required irrigation and light debridement.

• Common Device Name: GAUZE,SPONGE,4X4,8PLY,NS,LF,200/PK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 9071694
• Report Number: 1417592-2019-00151
• Device Sequence Number: 3731006
• Product Code: NAB
• UDI-Device Identifier: 10080196694013
• UDI-Public: 10080196694013
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2019

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: PRM21408CZ
• Device Lot Number: 6051904101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 09/16/2019
• 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: Required Intervention