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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC SET: 2-LUMEN 4 FR X 13 CM; PEDIATRIC MULTI LUMEN CATHETER PRODU

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ARROW INTERNATIONAL INC. CVC SET: 2-LUMEN 4 FR X 13 CM; PEDIATRIC MULTI LUMEN CATHETER PRODU Back to Search Results
Catalog Number CS-14402
Device Problem Unraveled Material (1664)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/05/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).This report is for the first in a series of three consecutive product issues with the same patient.The subsequent two events have been reported under mdr#s 1036844-2015-00592 and 1036844-2015-00593.
 
Event Description
It was reported the catheter was being placed into the left subclavian vein of a few month old child in the pediatric icu.During insertion, the guide wire unraveled.As a result, a new kit was used.
 
Manufacturer Narrative
(b)(4).Device evaluation: the reported event was confirmed through examination of a returned product sample.The customer returned a guidewire inserted through a catheter that was severely bent at the distal tip.The guidewire was unraveled and microscopic examination revealed that the core wire was separated 1.5 cm from the weld at the j-tip.No pieces of wire appeared to be missing.A lab inventory wire was able to pass through the catheter with slight resistance at the bend.The device history records for the guide wire and catheter were reviewed with no relevant findings.The provided instructions caution that withdrawing the guidewire against the needle bevel or use of excessive force during removal could damage or break the wire.Since it appears that the catheter was kinked during insertion resulting in damage to the guidewire, operational context caused or contributed to this event.No further action will be taken.
 
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Brand Name
CVC SET: 2-LUMEN 4 FR X 13 CM
Type of Device
PEDIATRIC MULTI LUMEN CATHETER PRODU
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
312 commerce place
asheboro NC 27203
Manufacturer Contact
john george
2400 bernville road
reading, PA 19605
6103780131
MDR Report Key5309791
MDR Text Key33842496
Report Number1036844-2015-00591
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K862056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/14/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2020
Device Catalogue NumberCS-14402
Device Lot Number23F15A1312
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/29/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/14/2015
Initial Date FDA Received12/18/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/05/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/21/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Weight3
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