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

Model Number DYNJ69124A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Needle Stick/Puncture (2462)

Event Date 03/07/2023

Event Type  Injury  

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.

Event 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.".

• Brand Name: MEDLINE INDUSTRIES, INC.
• Type of Device: 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: 16591217
• MDR Text Key: 311765873
• Report Number: 1423395-2023-00013
• Device Sequence Number: 1
• Product Code: OJH
• UDI-Device Identifier: 10195327226640
• UDI-Public: 10195327226640
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other