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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SURGE CARDIOVASCULAR ANTEGRADE CARDIOPLEGIA CANNULA
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SURGE CARDIOVASCULAR ANTEGRADE CARDIOPLEGIA CANNULA Back to Search Results
Catalog Number ANT-1014S
Device Problems Delivered as Unsterile Product (1421); Component Missing (2306); Tear, Rip or Hole in Device Packaging (2385); Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Information (3190)
Event Date 04/24/2018
Event Type  malfunction  
Manufacturer Narrative
Complaint was confirmed via return sample which showed the tip protector off the arota root tip which yielded a sterile barrier breach in the pouch.
 
Event Description
The needle does not have the protective cover attached and it has perforated the packaging.
 
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Brand Name
ANTEGRADE CARDIOPLEGIA CANNULA
Type of Device
CANNULA
Manufacturer (Section D)
SURGE CARDIOVASCULAR
2680 walker ave nw, suite c
walker MI 49544
Manufacturer (Section G)
SURGE CARDIOVASCULAR
2680 walker ave nw, suite c
walker MI 49544
Manufacturer Contact
kelli jonas
2680 walker ave nw, suite c
walker, MI 49544
6168869463
MDR Report Key7516414
MDR Text Key108752860
Report Number3004986960-2018-00001
Device Sequence Number1
Product Code DWF
Combination Product (y/n)N
PMA/PMN Number
K964198
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial
Report Date 05/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/01/2021
Device Catalogue NumberANT-1014S
Device Lot Number00559-110617
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/02/2018
Was the Report Sent to FDA? No
Date Manufacturer Received04/24/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/06/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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