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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MAJOR BASIN

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MEDLINE INDUSTRIES INC. MAJOR BASIN Back to Search Results
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.

 
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Type of DeviceMAJOR 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 Key11618422
MDR Text Key246071114
Report Number1423395-2021-00018
Device Sequence Number1
Product Code LRO
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
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 Received04/06/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberDYNJ905735A
Device LOT Number20LKA045
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/15/2021
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/09/2021
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 04/06/2021 Patient Sequence Number: 1
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