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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; PACK EYE

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MEDLINE INDUSTRIES, LP; PACK EYE Back to Search Results
Model Number DYNJ60113C
Device Problem Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/08/2024
Event Type  malfunction  
Manufacturer Narrative
It was reported that a syringe component was noted to have black staining within the barrel.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.A sample was returned for evaluation.The sample was filled with liquid and inside there appeared to be a dark greyest stain or material that appeared to be embedded with the material of the syringe.In an abundance of caution, and in response to an fda 483 issued for cfn 1417592 on 22-jan-2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.
 
Event Description
It was reported that a syringe component was noted to have black staining within the barrel.
 
Manufacturer Narrative
Update made to d2 product information.
 
Event Description
It was reported that a syringe component was noted to have black staining within the barrel.
 
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Type of Device
PACK EYE
Manufacturer (Section D)
MEDLINE INDUSTRIES, LP
three lakes drive
northfield IL 60093 2753
Manufacturer Contact
nigel vilches
three lakes drive
northfield, IL 60093-2753
MDR Report Key18881117
MDR Text Key337441360
Report Number1423395-2024-00317
Device Sequence Number1
Product Code OJK
UDI-Device Identifier40195327177479
UDI-Public40195327177479
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 Other
Type of Report Initial,Followup
Report Date 05/28/2024
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberDYNJ60113C
Device Lot Number23IMH496
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/16/2024
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/08/2024
Initial Date FDA Received03/11/2024
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/28/2024
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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