MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE INDUSTRIES, INC.; LAPAROSCOPY BASIN PACK

Model Number	DYNJ44723D
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Email received by facility representative, (b)(6) hospital, with additional information related to this reported incident.Reporter states, fibers of the raytec/gauze were noted to be coming apart/shredding into the breast/axillary surgical site during a breast surgery procedure.Reporter confirms the raytec/gauze sponges were "most likely sometime through the case one used to wipe the instruments." reporter states surgeon picked out fibers by hand, irrigation and forceps.All fibers were reported to be removed from the patient's surgical site.No report of serious injury.Reporter states, "no post-operative complications have been reported at this time." samples have been returned for evaluation.Investigation summary reads as follows; "the account reported finding raytec sponges are shredding.The reported issue occurred in item dynj44723d (lot 21bdb918).Based on the information provided, the reported issue appears to be a vendor product issue." due to the reported incident, medical intervention and in an abundance of caution, this med watch is being filed.If any further relevant information is identified or obtained, a supplemental med watch will be submitted.
Event or Problem Description
It was reported; raytec/gauze sponges are shredding from the laparoscopy basin packs and leaving small pieces of gauze in the wound.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: LAPAROSCOPY BASIN PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 11803066
• Report Number: 1423395-2021-00027
• Device Sequence Number: 16396357
• Product Code: FDE
• UDI-Device Identifier: 10193489264234
• UDI-Public: 10193489264234
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/10/2021

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 Model Number: DYNJ44723D
• Device Catalogue Number: DYNJ44723D
• Device Lot Number: 21BDB918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 05/10/2021
• 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