MAUDE Adverse Event Report: CARDINAL HEALTH DERMACEA GZE SPG 4X4 12PLY STR; GAUZE/SPONGE,NONRESORBABLE FOR EXTERNAL USE

Model Number	441000
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that the gauze is fraying when used.Additional information received stated that the gauze was used in the operating room and delivery room.When the doctors use it and remove it from where they place it in the patient, the thread comes out and the gauze frays little by little; the thread doesn¿t come out completely.
Additional Manufacturer Narrative
The device history record (dhr) review was performed showing no exception that could lead to the reported incident.No sample was available for investigation; however, a photo was provided.There is no abnormal phenomenon found on the sample photo.The supplier checked their retained sample and found no fraying.The supplier performs a quality inspection during the process.From the investigation, there is no abnormalities found in production process, retained sample, or the dhr.The supplier is unable to determine the root cause.The relevant sectors of manufacturing were informed of the complaint information for their awareness.There is no action taken at this time.The supplier will continue to monitor the trend of this type of incident.

• Brand Name: DERMACEA GZE SPG 4X4 12PLY STR
• Common Device Name: GAUZE/SPONGE,NONRESORBABLE FOR EXTERNAL USE
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 15319254
• Report Number: 1282497-2022-10717
• Device Sequence Number: 14760121
• Product Code: NAB
• UDI-Device Identifier: 10884521066038
• UDI-Public: 10884521066038
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2022

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
• Device Model Number: 441000
• Device Catalogue Number: 441000
• Device Lot Number: 210930-128-SH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2022
• Supplement Date Received by Manufacturer: 08/19/2022
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 09/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown