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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CADD MEDICATION CASSETTE; INTRAVASCULAR ADMINISTRATION SET
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CADD MEDICATION CASSETTE; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 21-7309-24
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
It was reported that the device leaked.No known adverse effects to patient.
 
Manufacturer Narrative
Device evaluation: one picture showing a plastic bag containing a cadd medication cassette, part number 21-7309-24, was received for evaluation.Some drops were visible in the plastic bag.No thorough inspection could be performed as no physical samples were returned.A review of manufacturing processes was performed.It was verified that procedures in the assembly process were being properly followed.As no lot number was available, a further review into the device manufacturing records could not be conducted.Based on the available information the complaint allegation was not confirmed.A picture of the cadd medication cassette, showing the cassette in a plastic bag, was recevied for evaluation on 13-jun-2019.
 
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Brand Name
CADD MEDICATION CASSETTE
Type of Device
INTRAVASCULAR ADMINISTRATION SET
MDR Report Key8197195
MDR Text Key131479135
Report Number3012307300-2018-05274
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586032387
UDI-Public10610586032387
Combination Product (y/n)N
PMA/PMN Number
K081156
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 07/26/2019
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
Device Operator No Information
Device Catalogue Number21-7309-24
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/29/2018
Initial Date FDA Received12/26/2018
Supplement Dates Manufacturer Received06/27/2019
Supplement Dates FDA Received07/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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