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

Catalog Number DYNJ46490G

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/26/2018

Event Type  Injury  

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 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.

• Type of Device: NEEDLE IN MINOR ORTHO TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 7494121
• MDR Text Key: 107584806
• Report Number: 1423395-2018-00023
• Device Sequence Number: 1
• Product Code: OJH
• UDI-Device Identifier: 10889942755721
• UDI-Public: 10889942755721
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 120