MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; CSC-N EXTREMITY

Catalog Number	DYNJ62445A
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
"chads" in a patient cavity.
Additional Manufacturer Narrative
It is reported that the pieces were from the clear packaging due to "punching holes in clear baggies".It was reported that the pieces had to be removed from a wound.A sample was requested to be returned for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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.
Additional Manufacturer Narrative
Added expiration date that was not included in the original report.

• Common Device Name: CSC-N EXTREMITY
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17694737
• Report Number: 1423395-2023-00051
• Device Sequence Number: 20409750
• Product Code: OJH
• UDI-Device Identifier: 10195327165673
• UDI-Public: 10195327165673
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2024

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
• Device Catalogue Number: DYNJ62445A
• Device Lot Number: 23EBV595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/06/2023
• Supplement Report FDA Received Date: 10/10/2024
• 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