MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP Medline Industries, Inc.; BASIC PACK

Model Number	DYNJ44105B
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, the sponge was 'fracturing causing fragments to be left in the surgical wound' while being used during a surgical procedure.According to the facility the fragments were able to be removed and irrigated.The customer reported that there has been no patient injury at this time.The sample was returned for evaluation and a definitive root cause could not be determined.No additional information is available at this time.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the customer, the sponge was 'fracturing causing fragments to be left in the surgical wound.'.

• Brand Name: Medline Industries, Inc.
• Common Device Name: BASIC PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 15717305
• Report Number: 1423395-2022-00034
• Device Sequence Number: 20488103
• Product Code: LRO
• UDI-Device Identifier: 10195327001377
• UDI-Public: 10195327001377
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/02/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: DYNJ44105B
• Device Catalogue Number: DYNJ44105B
• Device Lot Number: 22HBQ817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 11/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown