MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE INDUSTRIES, INC.; SHOULDER BEACH CHAIR PACK-LF

Model Number	DYNJ69124A
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	03/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, there was an incident when using the shoulder scope pack, where after placement was found with the spinal need "the inner stilet was stuck".
Additional Manufacturer Narrative
According to the customer, there was an incident when using the shoulder scope pack, where after placement was found with the spinal need "the inner stilet was stuck".The customer reported an additional spinal needle was required to be inserted in order to complete the procedure.The customer reported the individual made a full recovery, there was no follow-up care, and no additional intervention was required.Sample was requested for return evaluation.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.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
Update to h6: investigation conclusions.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: SHOULDER BEACH CHAIR PACK-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16590980
• Report Number: 1423395-2023-00012
• Device Sequence Number: 4947990
• Product Code: OJH
• UDI-Device Identifier: 10195327226640
• UDI-Public: 10195327226640
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 06/05/2023

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: DYNJ69124A
• Device Catalogue Number: DYNJ69124A
• Device Lot Number: 22KMA608
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2023
• Supplement Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 06/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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