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U.S. Department of Health and Human Services

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

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ARROW INTERNATIONAL INC. ARROW CVC KIT: 4-LUMEN 8.5FR X 20CM; CATHETER, INTRAVASCULAR, THERAPEUTIC Back to Search Results
Catalog Number CS-45854-HP
Device Problem Insufficient Information (3190)
Patient Problems Erythema (1840); Low Blood Pressure/ Hypotension (1914); Reaction (2414)
Event Date 05/01/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).It is reported that the patient had no known allergies.
 
Event Description
It was reported that: patient was going to operating theatres for a cardiac procedure.The patient received im midazolam on the ward then iv midazolam in the anesthetic bay.Skin had been prepped using chg wipe and chg cvc was inserted in anesthetic bay.Within minutes of line being put in the patient started getting red skin over trunk, arms and legs, extremely low bp and heart rate.Adrenaline was administered and symptoms resolved.Plain triple lumen cvc was then inserted, and procedure could continue.
 
Manufacturer Narrative
(b)(4).The customer returned one 4-lumen cvc and lidstock for evaluation.The catheter contained obvious signs of use in the form of biological material.Visual examination of the catheter did not reveal any defects or anomalies.The catheter coating appeared typical with no discoloration.The total length of the catheter body measured to be 216 mm , which is within specifications of 207-227 mm per product drawing.The returned catheter was flushed using a lab inventory syringe to ensure no blockages were present.The catheter flushed as expected.The distal end of the catheter was occluded and each extension line was pressurized using a water-filled lab inventory syringe.No leaks were detected.Additional testing of the catheter coating could not be performed as the catheter was inserted into the patient.Once the catheter is inserted, the coating begins releasing into the bloodstream.A device history record review was performed with no relevant findings.The instructions-for-use provided with this kit states, "use of arrowg+ard blue plus antimicrobial catheter technology is contraindicated for patients with known hypersensitivity to chlorhexidine, silver sulfadiazine and/or sulfa drugs." the customer indicated that the patient had no known allergies.The customer report of an allergic reaction could not be confirmed by complaint investigation of the returned catheter.The catheter passed all relevant visual, dimensional, and functional testing.A device history record review was performed with no relevant findings.The customer stated that the patient had no known allergies and no issues were found with the returned catheter; therefore, the probable root cause could not be determined.Teleflex will continue to monitor and trend for complaints of this nature.
 
Event Description
It was reported that: patient was going to operating theatres for a cardiac procedure.The patient received im midazolam on the ward then iv midazolam in the anesthetic bay.Skin had been prepped using chg wipe and chg cvc was inserted in anesthetic bay.Within minutes of line being put in the patient started getting red skin over trunk, arms and legs, extremely low bp and heart rate.Adrenaline was administered and symptoms resolved.Plain triple lumen cvc was then inserted, and procedure could continue.
 
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Brand Name
ARROW CVC KIT: 4-LUMEN 8.5FR X 20CM
Type of Device
CATHETER, INTRAVASCULAR, THERAPEUTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key10062589
MDR Text Key191159097
Report Number3006425876-2020-00431
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/01/2020
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 Health Professional
Device Expiration Date05/14/2021
Device Catalogue NumberCS-45854-HP
Device Lot Number71F19F0453
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/19/2020
Initial Date Manufacturer Received 05/01/2020
Initial Date FDA Received05/15/2020
Supplement Dates Manufacturer Received05/29/2020
Supplement Dates FDA Received05/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age76 YR
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