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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 4-LUMEN 8.5FR X 16CM CATHETER, INTRAVASCULAR, THERAPEUTIC

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ARROW INTERNATIONAL INC. ARROW CVC SET: 4-LUMEN 8.5FR X 16CM CATHETER, INTRAVASCULAR, THERAPEUTIC Back to Search Results
Catalog Number CV-22854
Device Problem Material Separation (1562)
Patient Problems Air Embolism (1697); No Information (3190)
Event Date 01/27/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). At present, the device sample is retained by the user facility. Additional information regarding this event and patient condition requested, but not received at the time of this report.
 
Event Description
A report was received that there was a damaged lumen on the central line snapped half-way down along the tubing. The central line was inserted on (b)(6) 2017 in the right internal jugular vein for the purpose of medication administration and monitoring purposes the facility reported there was a significant injury to patient due to an air embolism and the patient became peri-arrest. The patient was placed on a mechanical ventilator and admitted to intensive care. The patient required inotropic support to maintain cardiac output. The patient remains gravely ill. Diagnosis of the air embolism was confirmed by aspiration of free air from patient's right-sided cardiac circulation, and confirmed on echocardiographic ultrasound evaluation. After the leak was observed, the central line was clamped, removed and entire line and attached drips retained.
 
Manufacturer Narrative
(b)(4). Additional information received regarding the condition of the patient: the patient was unwell prior to insertion of central line. Patient discharged from critical care and is recovering well on surgical ward. Investigation results: a 4-lumen catheter marked 8. 5fr x 16cm on the juncture hub was returned for evaluation. The medial 2 extension line was separated 2. 8cm from the juncture hub. Under microscopic examination, it was observed that the ends of the separated extension line had striations in the surface. The edges of the extension line tubing were sharp and did not appear to be torn. A simulation was performed by cutting an extension line of a lab sample with medical scissors and examining the cut end. Microscopic examination revealed striations in the end of the tubing that appeared very similar to the complaint sample. A device history record (dhr) review could not be performed since the lot number was unknown. The instructions for use (ifu) contains a precaution not to use scissors to remove dressing to minimize the risk of cutting the catheter. The appearance of the separated tubing was consistent with being cut by medical scissors and was replicated by a simulation using a lab sample. Based on the complaint sample and the lab simulation, it was determined that operational context caused this event.
 
Event Description
A report was received that there was a damaged lumen on the central line snapped half-way down along the tubing. The central line was inserted on (b)(6) 2017 in the right internal jugular vein for the purpose of medication administration and monitoring purposes the facility reported there was a significant injury to patient due to an air embolism and the patient became peri-arrest. The patient was placed on a mechanical ventilator and admitted to intensive care. The patient required inotropic support to maintain cardiac output. The patient remains gravely ill. Diagnosis of the air embolism was confirmed by aspiration of free air from patient's right-sided cardiac circulation, and confirmed on echocardiographic ultrasound evaluation. After the leak was observed, the central line was clamped, removed and entire line and attached drips retained.
 
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Brand NameARROW CVC SET: 4-LUMEN 8.5FR X 16CM
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL CR, A.S.
jamska 2359/47
zdar nad sazavou 591 0 1
EZ 591 01
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key6349687
MDR Text Key68034409
Report Number3006425876-2017-00057
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCV-22854
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/17/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/31/2017
Was Device Evaluated by Manufacturer? Yes
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: 02/22/2017 Patient Sequence Number: 1
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