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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 Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem Tachycardia (2095)
Event Date 12/27/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The complaint is reported as: "after placement, xray taken post picc placement in course of ongoing medical care and per ir read picc recommended to be pulled 5cm. In looking back at notes picc was placed on 12/27 with case end time around 1100. Shortly after 1100 pt had an episode of symptomatic (fluttering and chest pressure) svt with rates sustaining 200s which self-terminated after 15 minutes. She did not have any additional episodes of svt since. Patient in seemingly in poor position when xray taken to confirm line placement ' xray ordered and recommendations remained unchanged. Based on xray estimates picc pulled 4cm and correct placement confirmed. Line was at 43 internal and 3 external/post pullback line is 40 internal and 7 external. Pt is 5ft. " the patient's condition is reported as fine.
 
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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
MDR Report Key11177383
MDR Text Key227353722
Report Number1036844-2021-00014
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,user f
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2021
Device Catalogue NumberCDC-45052-VPS2
Device Lot Number23F20H0094
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/08/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/05/2020
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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