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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW AGBA PICC/DELTA KIT: 1-L 4.5 FR X 50 CM INTRODUCER, CATHETER

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ARROW INTERNATIONAL INC. ARROW AGBA PICC/DELTA KIT: 1-L 4.5 FR X 50 CM INTRODUCER, CATHETER Back to Search Results
Model Number IPN037304
Device Problem Component Misassembled (4004)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/03/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
When going to place a single lumen picc, the user found the kit had a triple lumen catheter instead of the single lumen catheter. No patient involvement.
 
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Brand NameARROW AGBA PICC/DELTA KIT: 1-L 4.5 FR X 50 CM
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.
ave. washington 3701
colonia panamericana, chihuahua
chihuahua 31200
MX 31200
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key13093384
MDR Text Key283092661
Report Number9680794-2021-00678
Device Sequence Number1
Product Code DYB
UDI-Device Identifier60801902120740
UDI-Public60801902120740
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberIPN037304
Device Catalogue NumberCDC-45041-VPS2
Device Lot Number13F21J1117
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received01/25/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/18/2021
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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