MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; PAIN MGMT/ PREF W. MED NDL

Catalog Number	PAIN0072K
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility on 04/19/2024 "the 27g needle from the pain tray was inserted into the patient's lower back, the needle was inserted up to the hub and when the physician attempted to adjust the needle from the side to side the needle broke off of the hub".Per the facility "the needle was unable to be removed and the patient was transferred to the hospital for surgery".The sample is not available for evaluation.No additional information is available at this time.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, 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 on 04/19/2024 "the 27g needle from the pain tray was inserted into the patient's lower back, the needle was inserted up to the hub and when the physician attempted to adjust the needle from the side to side the needle broke off of the hub".

• Common Device Name: PAIN MGMT/ PREF W. MED NDL
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes dr; northfield, IL 60093-2753
• MDR Report Key: 19320813
• Report Number: 1417592-2024-00602
• Device Sequence Number: 7592152
• Product Code: OFT
• UDI-Device Identifier: 10889942694754
• UDI-Public: 10889942694754
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/15/2024

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: PAIN0072K
• Device Lot Number: 24ALA934
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2024
• Initial Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 69 YR
• Patient Sex: Male
• Patient Weight: 77 KG