MAUDE Adverse Event Report: JIANERKANG MEDICAL CO., LTD MCKESSON BRANDS; TOWEL, OR STR BLU DISP

Catalog Number	16-6004-B
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that small particles are coming off the towels during surgery.It was communicated that this has occurred over the past couple of months resulting in the doctor and assistants having to pick the small particles out of wounds.No information was received regarding any serious injury as a result of this product issue.

• Brand Name: MCKESSON BRANDS
• Common Device Name: TOWEL, OR STR BLU DISP
• Manufacturer (Section D): JIANERKANG MEDICAL CO., LTD; no. 1 jianerkang road; zhixi town industrial zone, ji; changzhou city, jiangsu 21325 1; CH 213251
• MDR Report Key: 20027545
• Report Number: 1451040-2024-00041
• Device Sequence Number: 8600633
• Product Code: PUI
• UDI-Device Identifier: 20612479174690
• UDI-Public: 20612479174690
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/20/2024
• Report Date (Section F): 08/20/2024

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: 16-6004-B
• Device Lot Number: CJD02-02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/22/2024
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/20/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/20/2024