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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW AGBA PICC/DELTA FG: 2-L 5.5 FR X 50 CM INTRODUCER, CATHETER

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ARROW INTERNATIONAL INC. ARROW AGBA PICC/DELTA FG: 2-L 5.5 FR X 50 CM INTRODUCER, CATHETER Back to Search Results
Catalog Number CDC-45052-VPS2
Device Problem Migration (4003)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/22/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reports: picc line placed using vps navigation as an outpatient on 6/15 in rt basilic. Patient admitted on (b)(6) 2020 and chest x-ray obtained and per radiology report picc located in rt atrium and approx. 3. 5 cm too deep x-ray taken while patient standing retracted picc 2 cm and repeat x-ray taken at 45-degree angle picc in cavioatrial junction. Patient not on telemetry but no palpitations reported by patient.
 
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Brand NameARROW AGBA PICC/DELTA FG: 2-L 5.5 FR X 50 CM
Type of DeviceINTRODUCER, CATHETER
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 Key10240226
MDR Text Key200852712
Report Number1036844-2020-00198
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCDC-45052-VPS2
Device Lot Number23F1950409
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 Received08/19/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 07/07/2020 Patient Sequence Number: 1
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