MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; INJECTION NEEDLE FROM PAIN TRAY

Catalog Number	DYNJRA1118
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during a left occipital injection of bupivacaine 0.25%, omnipaque, and betamethasone, the 1 ½ inches gauge-25 injection needle (taken from the pain tray) broke off from the hub of the needle into the patient.Reportedly, no excessive force was applied against or to the needle and the incident reportedly occurred as end user was withdrawing the needle from the injection site.The needle was successfully retrieved through fluoroscopy-guided extraction.It was confirmed through x-ray that no needle fragment was left in patient.Per report, no additional sedation medication was required related to this incident.Due to the reported incident and required medical intervention to retrieve the needle from the patient, this medwatch is being filed.The sample is not available to be returned for evaluation.A definitive root cause could not be determined at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that an injection needle broke off from its hub into the patient.

• Common Device Name: INJECTION NEEDLE FROM PAIN TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8404024
• Report Number: 1417592-2019-00026
• Device Sequence Number: 10832231
• Product Code: OFT
• UDI-Device Identifier: 10889942899494
• UDI-Public: 10889942899494
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/08/2019

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 Catalogue Number: DYNJRA1118
• Device Lot Number: 18FBA666
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2019
• Initial Report FDA Received Date: 03/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 32 YR
• Patient Weight: 101