MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP Medline Industries, Inc.; SINGLE SHOT EPIDURAL TRAY

Model Number	PAIN0763
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the facility that the loss of resistance syringe 'failed' and an additional injection was needed to complete the procedure.
Additional Manufacturer Narrative
It was reported by the facility that the loss of resistance syringe 'failed' and an additional injection was needed to complete the procedure.According to the facility there were errors with the first procedure where the doctor stated the 'syringe wasn't allowing appropriate spread in the imaging'.Per the facility the next injection was able to be completed successfully after the doctor used 3 syringes.According to the doctor, 'the loss of resistance syringe did not have resistance and allowed the blue portion of the syringe to move freely within it'.The sample was not returned for evaluation.No additional information is available.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.

• Brand Name: Medline Industries, Inc.
• Common Device Name: SINGLE SHOT EPIDURAL 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: 13871352
• Report Number: 1417592-2022-00039
• Device Sequence Number: 4692623
• Product Code: OGE
• UDI-Device Identifier: 10888277565197
• UDI-Public: 10888277565197
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 03/23/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: PAIN0763
• Device Catalogue Number: PAIN0763
• Device Lot Number: 21KLB157
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2022
• Initial Report FDA Received Date: 03/23/2022
• 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