MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC EPIDURAL CATHETERIZATION KIT NRFIT; CATHETER, CONDUCTION, ANESTHETIC

Catalog Number OU-05500-NRO

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/12/2022

Event Type  malfunction  

Event Description

It was reported that a leak was found from the metal part at the tip of the lor syringe during use.Therefore, a new kit was used instead.

Manufacturer Narrative

Qn#(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that a leak was found from the metal part at the tip of the lor syringe during use.Therefore, a new kit was used instead.

Manufacturer Narrative

(b)(4).The customer reported the lor syringe was leaking where the metal tip connects to the glass syringe.The customer returned one opened kit.The glass 5ml lor syringe nrfit was removed and visually examined with and without magnification.Visual examination of the syringe revealed that the syringe appears typical with no observed defects or anomalies.A dimensional inspection was not required as a part of this complaint investigation.Functional testing was performed on the returned syringe using the lab leak tester per the parameters in amrq-000128 rev.4, section 7.3-positive pressure leakage.Water was aspirated into the syringe and the syringe was inverted to remove any air from the barrel.The tip of the syringe was then connected to the lab leak tester via tubing and pressure was applied.The syringe was tested at 10psi for 10 seconds.A leak was detected where the metal tip connects to the glass syringe.A device history record review was performed on the lor syringes with a potentially relevant finding.An nc was initiated for component s-05500-001an; lot# 71p20b0521 in regard to 8 syringes were found where the piston does not move freely.Not relevant to this c omplaint.The reported complaint of the lor syringe leaking where the metal tip connects to the glass syringe was confirmed based on the sample received.Visual examination of the returned sample did not reveal any defects or anomalies; however, functional testing revealed the lor syringe was found to be leaking where the metal tip connects to the glass syringe.A device history record review was performed on the lor syringes with no evidence to indicate a manufacturing related issue.However, based on the condition of the sample received, the potential root cause of this complaint issue is supplier related.A nonconformance has been initiated to further investigate this issue.No further action is required at this time.

• Brand Name: EPIDURAL CATHETERIZATION KIT NRFIT
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16086290
• MDR Text Key: 306792477
• Report Number: 3006425876-2023-00008
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: OU-05500-NRO
• Device Lot Number: 71F21K1061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2022
• Initial Date FDA Received: 01/03/2023
• Supplement Dates Manufacturer Received: 01/30/2023
• Supplement Dates FDA Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED