MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC EPIDURAL CATHETERIZATION SET: 19 GA; ANESTHESIA CONDUCTION CATHETER

Model Number	IPN046378
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Embolism/Embolus (4438); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The catheter was removed within 48hr after first surgery and the blood clot was found 40hrs after the removal.There was no catheter defect.Blood clots formed at the puncture site; the doctor performed laminar decompression surgery with both patients to stop the bleeding.
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.
Additional Manufacturer Narrative
Qn# (b)(4).A device history record review was performed on the epidural catheter and needle with no relevant findings.A design history review was performed for part # m-05001-001a, kz-005400-030, and kz-05400-002 as a part of this complaint investiga tion.There have been no material changes for these parts during the last two years that could have led to this complaint.A corrective action is not required at this time as a potential root cause could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed on the epidural catheter and needle with no relevant findings.The potential cause of this complaint could not be determined based upon the information provided and without the sample.No further action is required at this time.
Event or Problem Description
The catheter was removed within 48hr after first surgery and the blood clot was found 40hrs after the removal.There was no catheter defect.Blood clots formed at the puncture site; the doctor performed laminar decompression surgery with both patients to stop the bleeding.

• Brand Name: EPIDURAL CATHETERIZATION SET: 19 GA
• Common Device Name: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 14695016
• Report Number: 3006425876-2022-00566
• Device Sequence Number: 14746509
• Product Code: BSO
• UDI-Device Identifier: 40801902128407
• UDI-Public: 40801902128407
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K140110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/08/2023
• Device Model Number: IPN046378
• Device Catalogue Number: EC-05400-E
• Device Lot Number: 71F21E1251
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2022
• Supplement Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other; Hospitalization
• Patient Sex: Unknown