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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB+ CATHETER,INTRAVASCULAR,THERAP

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ARROW INTERNATIONAL INC. ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB+ CATHETER,INTRAVASCULAR,THERAP Back to Search Results
Catalog Number AK-45703-PB1A
Device Problems Break (1069); Kinked (1339)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/20/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). It is reported that the physicians are pulling swg against the bevel of the needle when in the patient to re-adjust. Physician(s) informed that this manipulation is against ifu.
 
Event Description
The customer reports: the physicians complained about kinking/shearing when they were manipulating it (swg) inside the needle and pulling back against the bevel of the needle. The users have been using different size insertion needle and swg (spring wire guide) combinations.
 
Manufacturer Narrative
(b)(4). Complaint verification testing could not be performed as no sample was returned for analysis. A device history record review was performed and no relevant findings were identified. Based on the report that the customer withdrew the guide wire against the needle bevel, it was determined that user error caused or contributed to this event. An in-service has been initiated for this issue.
 
Event Description
The customer reports: the physicians complained about kinking/shearing when they were manipulating it(swg)inside the needle and pulling back against the bevel of the needle. The users have been using different size insertion needle and swg (spring wire guide) combinations.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reports: the physicians complained about kinking/shearing when they were manipulating it(swg)inside the needle and pulling back against the bevel of the needle. The users have been using different size insertion needle and swg (spring wire guide) combinations.
 
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Brand NameARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB+
Type of DeviceCATHETER,INTRAVASCULAR,THERAP
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNACIONAL DE CHIHUAHUA S.A. DE C.V
ave. washington 3701, edificio 4
colonia complejo industrial, las americas
chihuahua 31114
MX 31114
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key7569396
MDR Text Key110093169
Report Number3003737899-2018-00069
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2019
Device Catalogue NumberAK-45703-PB1A
Device Lot Number13F18B0183
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/06/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/12/2018
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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