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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; DBD-PACK GYN LAPAROSCOPY CHRG

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MEDLINE INDUSTRIES, LP; DBD-PACK GYN LAPAROSCOPY CHRG Back to Search Results
Model Number DYNJ60236
Device Problems Crack (1135); Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/24/2019
Event Type  malfunction  
Event Description
It was reported that the syringe component was received with a "cracked wing.".
 
Manufacturer Narrative
It was reported that the syringe component was received with a "cracked wing." 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 and one of the sides of the barrel flange was noted to have cracked off.The reported problem/issue was confirmed, however, a root cause was unable to be determined.Due to the reported problem/issue, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
 
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Type of Device
DBD-PACK GYN LAPAROSCOPY CHRG
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 Key18802866
MDR Text Key337253062
Report Number1423395-2024-00067
Device Sequence Number1
Product Code OHD
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 02/27/2024
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 NumberDYNJ60236
Device Lot Number19GDA453
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/30/2019
Initial Date Manufacturer Received 12/24/2019
Initial Date FDA Received02/28/2024
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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