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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BBRAUN BBRAUN INFUSAMAT IV TUBING; SET, ADMINISTRATION, INTRAVASCULAR
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BBRAUN BBRAUN INFUSAMAT IV TUBING; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number REFENCE # 480257
Device Problem Protective Measures Problem (3015)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/22/2022
Event Type  malfunction  
Event Description
Tubing that is manufactured for iv infusions are not cut at the appropriate length to place into the iv infusion pump (all products are bbraun primary or secondary infusamat sets).The incorrect manufacturing is resulting in repriming and respiking medications and iv fluids on an ongoing basis.We are noting multiple tubing sets and lot numbers that are affected.Fda safety report id # (b)(4).
 
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Brand Name
BBRAUN INFUSAMAT IV TUBING
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BBRAUN
MDR Report Key15869773
MDR Text Key304461367
Report NumberMW5113497
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 Nurse
Type of Report Initial
Report Date 11/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberREFENCE # 480257
Device Lot Number0061843406
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
IV TUBING TOO SHORT (LOT 0061843406) (REF 480257); IV TUBING TOO SHORT (LOT 0061843406) (REF 480257); IV TUBING TOO SHORT (LOT 0061843406) (REF 480257); IV TUBING TOO SHORT (LOT 0061843406) (REF 480257); IV TUBING TOO SHORT (LOT 0061847175) (REF 490100); IV TUBING TOO SHORT (LOT 0061848287) (REF 490100) - 12 SETS TUBING; IV TUBING TOO SHORT(LOT 0061843406) (REF#480257); IV TUBING TOO SHORT(LOT 0061847041) (REF 490100); IV TUBING TOO SHORT(LOT 00VL845499) (REF 490100)
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