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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW CVC KIT CATHETER,INTRAVASCULAR,THERAPE

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ARROW CVC KIT CATHETER,INTRAVASCULAR,THERAPE Back to Search Results
Catalog Number VASCULAR UNKNOWN
Device Problem Biocompatibility (2886)
Patient Problem Anaphylactic Shock (1703)
Event Date 09/15/2017
Event Type  Injury  
Manufacturer Narrative
Qn#: (b)(4).
 
Event Description
Through a review of records the customer reports a suspected allergic reaction to an arrow catheter. The following is reported: patient required admission to icu in (b)(6) 2017 due to a copd exacerbation and respiratory failure. After sedation and intubation, central line placed for vasopressor support. After the central line was inserted, developed hypotension, generalized urticaria, and increased airway pressures. Treated for anaphylaxis with an epinephrine infusion, antihistamines and corticosteroids with good response. Potential culprit exposures were piperacillin tazobactam, latex, chlorhexidine (from the line) and cisatracurium. Subsequently, tested positive to chlorhexidine skin prick test (11 mm) and chlorhexidine intradermal test at 22 mm. He tested negative to latex and cisatracurium. Histamine control was 5 mm via skin prick test, and saline control was 2 mm. Patient condition reported to be fine.
 
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Brand NameARROW CVC KIT
Type of DeviceCATHETER,INTRAVASCULAR,THERAPE
MDR Report Key12579511
MDR Text Key277405284
Report Number9680794-2021-00506
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K993691
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberVASCULAR UNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/05/2021 Patient Sequence Number: 1
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