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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. NEEDLE IN CSMC SHOULDER PACK

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MEDLINE INDUSTRIES INC. NEEDLE IN CSMC SHOULDER PACK Back to Search Results
Catalog Number DYNJ0665368B
Device Problem Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 04/20/2017
Event Type  Injury  
Manufacturer Narrative

Multiple attempts were made to contact the account to obtain additional details. The original notification stated a "needle broke off into the patient arm". It is unknown how the needle was being used, how the needle broke, or where in the arm the needle broke. It is unknown how the needle was removed from the patients arm. The sample was returned but a root cause cannot be determined. Due to the reported incident and in an abundance of caution this medwatch is being filed.

 
Event Description

It was reported a needle broke off into a patients arm.

 
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Type of DeviceNEEDLE IN CSMC SHOULDER PACK
Manufacturer (Section D)
MEDLINE INDUSTRIES INC.
three lakes drive
northfield IL 60093
Manufacturer Contact
megan debus
three lakes drive
northfield, IL 60093
MDR Report Key6575921
MDR Text Key75463107
Report Number1423395-2017-00015
Device Sequence Number1
Product Code OJH
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 05/18/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/18/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberDYNJ0665368B
Device LOT Number16FR0624
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received04/21/2017
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/18/2017 Patient Sequence Number: 1
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