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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC KIT: 3-LUMEN 7 FR X 20 CM ARROWG+ARD CATHETER PRODUCTS

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ARROW INTERNATIONAL INC. CVC KIT: 3-LUMEN 7 FR X 20 CM ARROWG+ARD CATHETER PRODUCTS Back to Search Results
Catalog Number CA-25703-A
Device Problems Break (1069); Material Separation (1562)
Patient Problem Embolus (1830)
Event Date 10/28/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported the catheter was being use in the patient's femoral vein in the msnicu. The health services manager stated there was an apparent "breakage/disconnect" where the distal lumen extension line met the hub. There was a presumed air embolism. As a result, the catheter was removed and a subclavian catheter was inserted. The patient responded to treatment for air embolism but no indication of the extent of injury. The patient has a traumatic brain injury. There was a delay in treatment and no patient death was reported.
 
Manufacturer Narrative
(b)(4). Device evaluation: the reported complaint of the distal extension line hub separated from the extension line was confirmed. The customer returned three pictures of the damaged catheter. The pictures show the distal hub separated from the distal extension line of the catheter. A piece of the tubing can be seen inside the separated hub and that the edge of the broken extension line is not smooth but uneven. No further information could be obtained from the pictures. A comprehensive investigation could not be performed because no sample was returned for analysis. The ifu for this product warns not to use excessive force when removing the guide wire and warns that the practitioner must be aware of potential embolisms and states to guard against it by following hospital protocol for catheter maintenance. It also caution the user that some disinfectants can weaken the catheter material and that each clamp must be opened prior to infusing through that lumen to minimize the risk of damaging the extension lines. A device history record review was not performed since the lot number was not provided and a potential lot number was not available. A risk evaluation was performed on this complaint. Therefore, the potential cause of the extension line hub separation. Other remarks: could not be determined based upon the information provided and without a sample. No further action will be taken.
 
Manufacturer Narrative
(b)(4). Device evaluation: the reported complaint of the distal extension line hub separated from the extension line was confirmed. The customer returned three pictures of the damaged catheter. The pictures show the distal hub separated from the distal extension line of the catheter. A piece of the tubing can be seen inside the separated hub and that the edge of the broken extension line is not smooth but uneven. No further information could be obtained from the pictures. At a later date, the customer returned the damaged catheter. Visual examination confirmed that the distal extension line hub was separated from the distal extension line just below the hub; no tubing was extending from the hub. The distal extension line was observed to be knotted off upon receipt but no marking were observed that could indicate how the tubing separated. Microscopic examination confirmed that both broken edges of the distal extension line tubing were rough indicating that it was torn apart. Microscopic examination also revealed that a significant piece of tubing was present inside the hub. A cross section of the distal hub revealed that the extension line was fully other remarks: inserted into the hub when compared to the extension line graphic. The ifu for this product warns not to use excessive force when removing the guide wire and warns that the practitioner must be aware of potential embolisms and states to guard against it by following hospital protocol for catheter maintenance. It also cautions the user that some disinfectants can weaken the catheter material and that each clamp must be opened prior to infusing through that lumen to minimize the risk of damaging the extension lines. A device history record review was not performed since the lot number was not provided and a potential lot number was not available. A risk evaluation was performed on this complaint. Operational context appears to have caused or contributed to this complaint. No further action will be taken.
 
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Brand NameCVC KIT: 3-LUMEN 7 FR X 20 CM
Type of DeviceARROWG+ARD CATHETER PRODUCTS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
312 commerce place
asheboro NC 27203
Manufacturer Contact
jamie hartz
2400 bernville road
reading, PA 19605
MDR Report Key6089872
MDR Text Key59503171
Report Number1036844-2016-00565
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K900263
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/02/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCA-25703-A
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/20/2016
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: 11/09/2016 Patient Sequence Number: 1
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