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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCKET MEDICAL PLC ROCKET; IPC 1000CC BOTTLE & DRESSING PACK
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ROCKET MEDICAL PLC ROCKET; IPC 1000CC BOTTLE & DRESSING PACK Back to Search Results
Model Number R51411
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/10/2022
Event Type  malfunction  
Event Description
Elderly male with history of coronary disease, congestive heart failure, decompensated severe congestive heart failure and right-sided pleurx catheter.Catheter was not draining with the first bottle, noticed that the bellow was open, and no drainage was filling into bottle.A 2nd bottle opened, and it too had the bellow open.The 3rd bottle used worked effectively.No known harm to patient.Manufacturer response for ipc 1000cc bottle & dressing pack, (brand not provided) (per site reporter).Will obtain.
 
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Brand Name
ROCKET
Type of Device
IPC 1000CC BOTTLE & DRESSING PACK
Manufacturer (Section D)
ROCKET MEDICAL PLC
50 corporate park drive #890
east pembroke MA 02359
MDR Report Key14416047
MDR Text Key292053777
Report Number14416047
Device Sequence Number1
Product Code PNG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 05/12/2022
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 Operator Health Professional
Device Model NumberR51411
Device Catalogue NumberR51411
Device Lot Number493750
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/12/2022
Event Location Other
Date Report to Manufacturer05/16/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/17/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient SexMale
Patient Weight93 KG
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