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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PSI KIT: 9 FR X 10 CM ANTIMICROBIAL CATHETER,INTRAVASCULAR,THERAP

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ARROW INTERNATIONAL INC. ARROW PSI KIT: 9 FR X 10 CM ANTIMICROBIAL CATHETER,INTRAVASCULAR,THERAP Back to Search Results
Catalog Number CDC-29903-X1A
Device Problem Mechanical Problem (1384)
Patient Problem Laceration(s) (1946)
Event Date 07/31/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reports: the kit usually has the shackleford safety scalpel (it is blue and red). A non-safety scalpel. The resident was cut by the non-safety scalpel. The user needed 5 stitches.
 
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Brand NameARROW PSI KIT: 9 FR X 10 CM ANTIMICROBIAL
Type of DeviceCATHETER,INTRAVASCULAR,THERAP
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
312 commerce place
asheboro NC 27203
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key8885051
MDR Text Key154021015
Report Number1036844-2019-00896
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K011761
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2020
Device Catalogue NumberCDC-29903-X1A
Device Lot Number23F19D0216
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/12/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/23/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/12/2019 Patient Sequence Number: 1
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