MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; NEEDLE IN MINOR ORTHO TRAY

Catalog Number	DYNJ46490G
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that while injecting a local anesthetic during a left breast tissue expander removal, the needle broke off into the patient's left breast.The broken needle piece was reportedly removed by the surgeon with a needle holder and tissue forceps.The procedure was completed without further incident.The patient was reportedly under general anesthesia at the time of the incident.No impact to the patient, the patient's stability, or the procedure was reported.A sample was returned to the manufacturer for evaluation.The reported product issue was confirmed but a root cause could not be determined.Due to the need for medical intervention, 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 injecting a local anesthetic during a left breast tissue expander removal, the needle broke off into the patient's left breast.

• Common Device Name: NEEDLE IN MINOR ORTHO TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 7494121
• Report Number: 1423395-2018-00023
• Device Sequence Number: 1416693
• Product Code: OJH
• UDI-Device Identifier: 10889942755721
• UDI-Public: 10889942755721
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/08/2018

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: DYNJ46490G
• Device Lot Number: 18BB3360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2018
• Initial Report FDA Received Date: 05/08/2018
• 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: Required Intervention
• Patient Age: 44 YR
• Patient Weight: 120