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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC PACING/PSI KIT: 5 FR/6 FR 2-L; CATHETER, ELECTRODE RECORDING
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ARROW INTERNATIONAL LLC PACING/PSI KIT: 5 FR/6 FR 2-L; CATHETER, ELECTRODE RECORDING Back to Search Results
Catalog Number AI-07155-IK
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/11/2023
Event Type  malfunction  
Manufacturer Narrative
Qn#(b)(4).
 
Event Description
It was reported that after the catheter was inserted, blood was flowing back into the sheath sleeve.It was found that there was a piece of the o-ring on the tray.It i unknown if it became dislodged from the sheath.As a result, the catheter was removed and 2nd catheter was inserted.No patient harm or injury.The patient status is reported as "fine".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.
 
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Brand Name
PACING/PSI KIT: 5 FR/6 FR 2-L
Type of Device
CATHETER, ELECTRODE RECORDING
Manufacturer (Section D)
ARROW INTERNATIONAL LLC
morrisville NC
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
16 elizabeth drive
chelmsford MA 01824
Manufacturer Contact
bryanna connelly
3015 carrington mill blvd
morrisville 27560
MDR Report Key17408343
MDR Text Key320016598
Report Number3010532612-2023-00427
Device Sequence Number1
Product Code DRF
Combination Product (y/n)N
Reporter Country CodeHK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 07/11/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2024
Device Catalogue NumberAI-07155-IK
Device Lot Number13F23A0331
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/25/2023
Date Manufacturer Received07/11/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/19/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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