MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; MAJOR BASIN

Catalog Number DYNJ905735A

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/01/2021

Event Type  Injury  

Manufacturer Narrative

It was reported that while a surgeon was injecting a medication into the patient's chest for an unreported procedure, the needle broke off completely in the patient's chest requiring additional intervention to remove the needle from the chest.The surgeon was able to open the patient's incision and push the needle slightly into the chest to retrieve it and the needle was taken out of the patient safely and still intact.There was no reported impact on the patient's stability as a result of the reported incident.The needle was returned to the manufacturer for evaluation.Upon physical inspection of the received sample it was seen that the needle was separated from the hub completely.No additional damage was seen on the needle that was received.The root cause could not be determined at this time.No additional information is available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be submitted.

Event Description

It was reported that while a surgeon was injecting a medication into the patient's chest for an unreported procedure, the needle broke off completely in the patient's chest requiring additional intervention to remove the needle from the chest.

• Type of Device: MAJOR BASIN
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 11618422
• MDR Text Key: 246071114
• Report Number: 1423395-2021-00018
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ905735A
• Device Lot Number: 20LKA045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Date Manufacturer Received: 03/09/2021
• 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