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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 4-LUMEN 8.5 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

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ARROW INTERNATIONAL INC. ARROW CVC SET: 4-LUMEN 8.5 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number CS-25854-E
Device Problem Insufficient Information (3190)
Patient Problems Low Blood Pressure/ Hypotension (1914); Reaction (2414); Bronchospasm (2598)
Event Date 02/15/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that: a patient, (b)(6) years of age, with a bowel obstruction was scheduled for surgery.She had a central line placed.Around 20 minutes into the procedure while under general anesthesia she developed bronchospasm and hypotension.She was stabilized and the procedure continued.Troubleshooting steps followed and it was suspected she had reacted to the chlorhexidine in the central line.This was removed.She had an elevated mast cell tryptase level post op, 21.3, normal upper limit 11.She went to icu, though she had major surgery.She had a difficult post op recovery, mostly related to her age and the extent of the surgery rather than the reaction.
 
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
 
Event Description
It was reported that: a patient, 81 years of age, with a bowel obstruction was scheduled for surgery.She had a central line placed.Around 20 minutes into the procedure while under general anesthesia she developed bronchospasm and hypotension.She was stabilized and the procedure continued.Troubleshooting steps followed and it was suspected she had reacted to the chlorhexidine in the central line.This was removed.She had an elevated mast cell tryptase level post op, 21.3, normal upper limit 11.She went to icu, though she had had major surgery.She had a difficult post op recovery, mostly related to her age and the extent of the surgery rather than the reaction.
 
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Brand Name
ARROW CVC SET: 4-LUMEN 8.5 FR X 20 CM
Type of Device
CATHETER INTRAVASCULAR THERAPE
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key9911633
MDR Text Key185980546
Report Number3006425876-2020-00287
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K962577
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date07/30/2020
Device Catalogue NumberCS-25854-E
Device Lot Number71F18H2399
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/19/2020
Initial Date FDA Received04/01/2020
Supplement Dates Manufacturer Received05/06/2020
Supplement Dates FDA Received05/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age81 YR
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