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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD BD EXTENSION SET SMALLBORE TUBING SET, ADMINISTRATION, INTRAVASCULAR

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BD BD EXTENSION SET SMALLBORE TUBING SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 10373772
Device Problems Crack (1135); Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/30/2022
Event Type  malfunction  
Event Description
Bd extension set smallbore tubing cracked and leaked chemotherapy. Fda safety report id# (b)(4).
 
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Brand NameBD EXTENSION SET SMALLBORE TUBING
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BD
MDR Report Key15183697
MDR Text Key297517032
Report NumberMW5111316
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 08/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number10373772
Device Lot Number(10)21059539
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/05/2022 Patient Sequence Number: 1
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