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U.S. Department of Health and Human Services

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

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ARROW INTERNATIONAL INC. 3-L CVC KIT: 7 FR X 20 CM ARROWG+ARD CATHETER PRODUCTS Back to Search Results
Catalog Number CDC-45703-A1A
Device Problems Bent (1059); Material Frayed (1262); Physical Resistance (2578)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/01/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). This report is the second of two consecutive product problems with the same patient. The first issue has been reported under mdr# 1036844-2016-00202.
 
Event Description
Per the complaint investigation of the samples received the dilator was also returned and was found to be damaged from resistance with the guide wire kinking.
 
Manufacturer Narrative
(b)(4). Device evaluation: the reported complaint of difficulty during insertion was confirmed. The customer returned one dilator. Visual examination of the returned dilator revealed that the body is slightly bent and the tip is damaged. Microscopic examination confirmed that the tip is flared out like a petal. White stress marks can be seen around the damaged tip. This type of damage is consistent with a difficult insertion and with the guide wire being pulled against the tip either during insertion or removal. The dilator was measured at 10. 0 cm which is within specification of 3. 75-4. 25 in (9. 525-10. 795 cm) per dilator graphic. The outside diameter of the dilator body is 0. 112 in. This is within specification of 0. 111-0. 113 in. Per dilator graphic. The ifu for this product states to enlarge the puncture site with the cutting edge of a scalpel positioned away from the guide wire which is already inserted into the patient. The insertion procedure used was not reported and therefore it is not known if a skin nick was performed prior to dilator insertion. The device history record review were reviewed and did not reveal any manufacturing related issues. Based upon the time of discovery and the information provided, operational context caused or contributed to this complaint. No further action will be taken.
 
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Brand Name3-L CVC KIT: 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 Key5571614
MDR Text Key42496352
Report Number1036844-2016-00212
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/08/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/12/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2017
Device Catalogue NumberCDC-45703-A1A
Device Lot Number23F15F1240
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/11/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/08/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/16/2015
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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