MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE INDUSTRIES, INC.; DBD-MAJOR GENERAL PROCEDURE PK-LF

Model Number	DYNJV0264I
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported, "two separate incidents in which, dr.(b)(6) had 2 cases (one this weekend/one this am) where he had to pick-out fragments of gauze from the abdomen." both incidents reported to medline industries, inc., (b)(6) 2021.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.Samples have not been returned for evaluation.Investigation summary: "the account reported finding gauze was fraying/flaking during use.The reported issue occurred in item dynjv0264i (lot 21bmb758).Based on the information provided, we are unable to confirm the reported issue without a photo or sample." 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.Investigation summary: "the account reported finding gauze was fraying/flaking during use.The reported issue occurred in item dynjv0264i (lot 21bmb758).Based on the information provided, we are unable to confirm the reported issue without a photo or sample." actions taken and recommendations: this complaint has been provided to the vendor for further evaluation.Our supplier quality team will also monitor this issue for trending purposes.".
Event or Problem Description
It was reported, "two separate incidents in which, dr.(b)(6) had 2 cases (one this weekend/one this am) where he had to pick-out fragments of gauze from the abdomen.".

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: DBD-MAJOR GENERAL PROCEDURE PK-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 11822539
• Report Number: 1423395-2021-00025
• Device Sequence Number: 17066935
• Product Code: LRO
• UDI-Device Identifier: 10193489487619
• UDI-Public: 10193489487619
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/13/2021

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: DYNJV0264I
• Device Catalogue Number: DYNJV0264I
• Device Lot Number: 21BMB758
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 05/13/2021
• 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