• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; DBD-PLASTIC PACK-LF

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDLINE INDUSTRIES, LP; DBD-PLASTIC PACK-LF Back to Search Results
Model Number DYNJ0781642P
Device Problem Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/03/2020
Event Type  malfunction  
Event Description
It was reported that a hair was found wrapped around the syringe component.
 
Manufacturer Narrative
It was reported that a hair was found wrapped around the syringe component when the surgical pack was opened.No death, serious injury, medical intervention, follow-up care, or other adverse patient/health impact has been reported to the manufacturer.The surgical pack was returned for evaluation a long piece of black hair was confirmed to be wrapped where a user's fingers would be placed and the barrel of the syringe.The root cause has been determined to likely be due to a supplier product issue.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 filed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of Device
DBD-PLASTIC PACK-LF
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 Key18659869
MDR Text Key334769541
Report Number1423395-2024-00012
Device Sequence Number1
Product Code FTN
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
Report Date 02/07/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberDYNJ0781642P
Device Lot Number19JMB133
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/13/2020
Initial Date Manufacturer Received 01/03/2020
Initial Date FDA Received02/07/2024
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
-
-