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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMMUCOR, INC. ANTI-D (MONOCLONAL BLEND); BLOOD GROUPING REAGENT
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IMMUCOR, INC. ANTI-D (MONOCLONAL BLEND); BLOOD GROUPING REAGENT Back to Search Results
Catalog Number 0066420
Medical Device Problem Code Device Damaged Prior to Use (2284)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/08/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The breakage appears to be attributed damage from shipping and handling.Immucor monitors complaints of broken vials via tracking & trending.The immucor internal report record number for this report is (b)(4).
 
Event or Problem Description
On (b)(6) 2019 a customer reported that they cut their finger on broken vial of anti-d (monoclonal blend).
 
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Brand Name
ANTI-D (MONOCLONAL BLEND)
Common Device Name
BLOOD GROUPING REAGENT
Manufacturer (Section D)
IMMUCOR, INC.
3130 gateway drive
norcross GA 30091 5625
MDR Report Key9180410
Report Number1034569-2019-00133
Device Sequence Number2626699
Product Code QHR
UDI-Device Identifier10888234001348
UDI-Public10888234001348
Combination Product (Y/N)N
Initial Reporter StateWI
Initial Reporter CountryUS
PMA/510(K) Number
BL103629
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 10/11/2019
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
Operator of Device No Information
Device Expiration Date11/05/2020
Device Catalogue Number0066420
Device Lot Number506281
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/08/2019
Initial Report FDA Received Date10/11/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age29 YR
Patient Weight136
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