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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 AK-45703-CDC
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/13/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported the central line fell out of the patient. The blue and white box clamp was sutured into place but did not hold the catheter in place. The catheter was able to slide through the clamp. There was no patient death or complications reported. Follow up information states the catheter was sutured in place and the patient was on pressors. The catheter was in use only a few hours before it fell out. This was discovered immediately by the nurse and there was no intervention required. The line was not replaced and was discontinued.
 
Manufacturer Narrative
Qn#(b)(4). Device evaluation: the report that the catheter migrated could not be confirmed. Returned were a catheter box clamp and a 3-lumen catheter marked 7fr x 20cm on the juncture hub. The box clamp was not on the catheter. The catheter and the box clamp appeared typical. The outside diameter of the catheter body extrusion measured 0. 097" using ring gauges. This met specification per the catheter graphic. The inner diameter of the clamp could not be measured since the clamp material is pliable and it had been used on a patient. The largest pin gauge that would pass through the clamp assembly without resistance was 0. 069". This indicates that the clamp would securely hold a catheter that has an od of 0. 097". The clamp and clamp fastener were assembled onto the catheter body adjacent to the 10cm mark. The catheter was tugged from either side and remained secure in the clamp. The device history records were reviewed based on sales history with no evidence to suggest a manufacturing related issue. No problem was found on the returned sample. No further action will be taken at this time.
 
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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 Key5751710
MDR Text Key48296808
Report Number1036844-2016-00340
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K993691
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/16/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/27/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberAK-45703-CDC
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
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

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