MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; DBD-20G EPIDURAL TRAY

Catalog Number	PAIN1074
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that while removing the epidural needle from the patient, a piece broke off and was retained in the insertion site.Reportedly, the needle was removed from the insertion site because the physician found that placement was not correct.The physician was required to create an incision at the needle insertion site and remove the broken needle piece with a clamp.Reportedly, this incision site was closed with a steri-strip.The patient was not under general anesthesia at the time of this incident.The intended unidentified procedure was reportedly cancelled and rescheduled.A used sample was returned to the manufacturer and the reported product issue was confirmed however no definitive root cause could be determined.No serious injury or follow-up care reported.No impact to patient stability reported.Due to the reported incident, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that while removing the epidural needle from the patient, a piece broke off and was retained in the insertion site.

• Common Device Name: DBD-20G EPIDURAL TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 7483569
• Report Number: 1417592-2018-00021
• Device Sequence Number: 160307
• Product Code: OGE
• UDI-Device Identifier: 10889942487585
• UDI-Public: 10889942487585
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/03/2018

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: Physician
• Device Catalogue Number: PAIN1074
• Device Lot Number: 17NB4712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2018
• Initial Report FDA Received Date: 05/03/2018
• 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: Other; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 77