MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC EPIDURAL CATHETERIZATION KIT NRFIT; Anesthesia conduction kit

Catalog Number OU-05500-NRO

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 10/24/2022

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).The device investigation is pending and will be submitted in a follow-up report.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the user felt resistance when sliding the plunger of lor syringe.Therefore, he/she used another lor syringe from a new kit to complete the procedure.

Manufacturer Narrative

Qn#(b)(4).The customer reported resistance was felt when sliding the plunger on the lor syringe.The customer returned one plastic injection syringe and lidstock.No lor syringe was returned.The returned injection syringe was visually examined with and without magnification.Visual examination of the returned syringe revealed the syringe appears typical with no observed defects or anomalies.A device history record review was performed on the glass and plastic lor syringes with a potentially relevant finding.An nc was initiated for component (b)(4); lot # 71p20j0057 in regard to the plunger not sliding in or out of the barrel.A corrective action is not required at this time as the root cause for this complaint investigation could not be determined based upon the information provided and the sample received.The reported complaint of the resistance being felt when sliding the plunger on the lor syringe could not be confirmed based on the sample received.An lor syringe was not returned, only an injection syringe was returned.A device history record review was performed on the glass and plastic lor syringes with a potentially relevant finding on the glass syringe for issues with the plunger sliding in and out of the barrel.However, this complaint investigation could not be determined based upon the information provided and the sample received.No further action is required at this time.

Event Description

It was reported that the user felt resistance when sliding the plunger of lor syringe.Therefore, he/she used another lor syringe from a new kit to complete the procedure.

• Brand Name: EPIDURAL CATHETERIZATION KIT NRFIT
• Type of Device: Anesthesia conduction kit
• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 15814411
• MDR Text Key: 308000477
• Report Number: 3006425876-2022-00991
• Device Sequence Number: 1
• Product Code: CAZ
• 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: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• 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: 71F21K0370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2021
• 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