MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP Medline Industries, Inc.; PAIN MANAGEMENT TRAY

Model Number	PAIN1224
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility the pack had a defective needle that was not able to be recovered from the patient.Per the facility, 'the needle was not able to be recovered and the patient was sent home with the needle still inside'.Per the facility, 'the needle will be attempted to be recovered when the customer goes back into the office'.The sample is available but has not been returned for evaluation.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 facility the pack had a defective needle that was not able to be recovered from the patient.

• Brand Name: Medline Industries, Inc.
• Common Device Name: PAIN MANAGEMENT TRAY
• 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: 15495897
• Report Number: 1417592-2022-00182
• Device Sequence Number: 14909227
• Product Code: OFT
• UDI-Device Identifier: 10889942832927
• UDI-Public: 10889942832927
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/27/2022

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: PAIN1224
• Device Catalogue Number: PAIN1224
• Device Lot Number: 22CLB110
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2022
• Initial Report FDA Received Date: 09/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown