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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL CENTRAL LINE KIT CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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TELEFLEX MEDICAL CENTRAL LINE KIT CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Catalog Number CDC-45703-XP1A
Device Problem Material Twisted/Bent (2981)
Patient Problem Insufficient Information (4580)
Event Date 02/05/2022
Event Type  malfunction  
Event Description
Central line kits guidewire bending upon insertion. Fda safety report id # (b)(4).
 
Event Description
Central line kits guidewire bending upon insertion. Fda safety report id # (b)(4).
 
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Brand NameCENTRAL LINE KIT
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
TELEFLEX MEDICAL
MDR Report Key13534687
MDR Text Key285647189
Report NumberMW5107425
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCDC-45703-XP1A
Device Lot Number23F21K0120
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes

Patient Treatment Data
Date Received: 02/15/2022 Patient Sequence Number: 1
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