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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HST III SEAL (4.5MM), 5-PACK CLAMP, VASCULAR

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MAQUET CARDIOVASCULAR LLC HST III SEAL (4.5MM), 5-PACK CLAMP, VASCULAR Back to Search Results
Model Number HST III SEAL (4.5MM), 5-PACK
Device Problem Fitting Problem (2183)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/22/2022
Event Type  malfunction  
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Brand NameHST III SEAL (4.5MM), 5-PACK
Type of DeviceCLAMP, VASCULAR
Manufacturer (Section D)
MAQUET CARDIOVASCULAR LLC
45 barbour pond drive
wayne NJ
Manufacturer (Section G)
MAQUET CARDIOVASCULAR LLC
45 barbour pond drive
wayne NJ
Manufacturer Contact
arelean guzman
45 barbour pond drive
wayne, NJ 
MDR Report Key15027089
Report Number2242352-2022-00614
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
PMA/PMN Number
K130382
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/11/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberHST III SEAL (4.5MM), 5-PACK
Device Catalogue NumberC-HS-3045
Device Lot Number25163520
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/05/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/17/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/28/2022
Is the Device Single Use? Yes
Type of Device Usage Initial

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