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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC SET: 3-LUMEN 8.5FR X 20CM ARROWG+ARD CATHETER PRODUCTS

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ARROW INTERNATIONAL INC. CVC SET: 3-LUMEN 8.5FR X 20CM ARROWG+ARD CATHETER PRODUCTS Back to Search Results
Catalog Number CS-25853-E
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/26/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that: "the nurse noticed that the catheter was almost out. The blood dripped through the tube.
 
Manufacturer Narrative
Qn#(b)(4). Device evaluation: the report that the catheter migrated could not be confirmed. Returned was a 3-lumen catheter marked 8. 5fr x 20cm on the hub. The catheter clamp was attached between 2 and 4 cm from the distal tip. The clamp held securely when tugged from either side. The clamp was disassembled and removed from catheter. The od of the catheter body extrusion measured 0. 116" using ring gauges. This met specification per the catheter extrusion graphic. The id of the clamp could not be measured since the clamp material is pliable and it had been used on a patient. The clamp and the clamp fastener were reassembled. The largest pin gauge that would pass through the clamp assembly without resistance was 0. 098". This indicates that the clamp would securely hold a catheter that has an od of 0. 116". The clamp and clamp fastener were assembled onto the catheter body between 13 and 15 cm from the catheter tip. The catheter was tugged from either side and remained secure in the clamp. It was not reported by the customer whether or not the juncture hub was used as the primary suture site per the instruction booklet. The device history records were reviewed and found no manufacturing related issues. No problem was found on the returned sample. No further action will be taken at this time.
 
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Brand NameCVC SET: 3-LUMEN 8.5FR X 20CM
Type of DeviceARROWG+ARD CATHETER PRODUCTS
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
jamie hartz
2400 bernville road
reading, PA 19605
MDR Report Key5970143
MDR Text Key55443890
Report Number3006425876-2016-00298
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeFR
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
Report Date 08/30/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/22/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2018
Device Catalogue NumberCS-25853-E
Device Lot Number71F16F1454
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/15/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/30/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/21/2016
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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