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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALLINCKRODT DAR SRL DAR; FIBRINOGEN AND SPLIT PRODUCTS, RHODAMINE, ANTIGEN, ANTISERUM, CONTROL
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MALLINCKRODT DAR SRL DAR; FIBRINOGEN AND SPLIT PRODUCTS, RHODAMINE, ANTIGEN, ANTISERUM, CONTROL Back to Search Results
Model Number 352/5996Z
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Patient Involvement (2645)
Event Date 10/12/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, the unit had breakage in the sterilization back.There was no patient involvement.
 
Manufacturer Narrative
Evaluation summary: one sample was received with a scratch on the plastic film side.We can suppose that the damage on the plastic film was caused by an abnormal mechanical stress after the manufacturing phase, probably occurred after the contact with a sharp-edge object.A 100% visual check was performed during the packaging phase, so this kind of damage would have been found and scrapped in production.Information has been added to the database and trends will continue to be monitored.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
DAR
Type of Device
FIBRINOGEN AND SPLIT PRODUCTS, RHODAMINE, ANTIGEN, ANTISERUM, CONTROL
Manufacturer (Section D)
MALLINCKRODT DAR SRL
via giacomo bove 2/4/6/8
mirandola 41037
IT  41037
MDR Report Key8047189
MDR Text Key126519240
Report Number2936999-2018-00674
Device Sequence Number1
Product Code DAR
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,user faci
Type of Report Initial,Followup
Report Date 03/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/01/2023
Device Model Number352/5996Z
Device Catalogue Number352/5996Z
Device Lot Number18B1118FAX
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/22/2019
Date Manufacturer Received03/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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