MAUDE Adverse Event Report: EPIDURAL CATHETERIZATION SET; ANESTHESIA CONDUCTION KIT

Model Number IPN046311

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 11/28/2020

Event Type  malfunction  

Manufacturer Narrative

(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 the incident happened at the hosiptal on (b)(6) 2020.The plunger of the syringe is not sealed in the barrel.It slides down by itself.Additional information: the incident was observed at the beginning of the intervention.There were no consequences for the patient or medical intervention.

Manufacturer Narrative

Qn#(b)(4).A device history record review was performed on the lor syringe with no relevant findings.The customer reported issues with resistance for the lor syringe.The customer returned one empty kit with one 10ml plastic lor syringe.The syringe was visually examined.Visual examination of the syringe revealed that the syringe appears typical with no observed defects or anomalies.The returned lor syringe was compared to a lab inventory syringe by sliding the plunger into the barrel of the syringe.The resistance of the returned lor syringe was comparable to the lab inventory syringe.The returned sample was returned to the supplier (preox) for leak testing.According to the supplier, no leak was found with the returned sample.The returned sample was returned to the supplier (preox) for functional testing.No issues were found with the returned sample.The reported complaint of issues with resistance for the lor syringe could not be confirmed based on the sample received.The returned lor syringe when compared to a lab inventory syringe had comparable resistance when sliding the plunger into the barrel of the syringe.The returned lor syringe was returned to the supplier (preox) for leak testing where no issues were found.A device history record review was performed on the lor syringe with no evidence to suggest a manufacturing related issue.Based on the supplier's results, no issues were found with the returned sample.

Event Description

It was reported that the incident happened at the hosiptal on (b)(6)2020.The plunger of the syringe is not sealed in the barrel.It slides down by itself.Additional information: the incident was observed at the beginning of the intervention.There were no consequences for the patient or medical intervention.

• Brand Name: EPIDURAL CATHETERIZATION SET
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 10943115
• MDR Text Key: 219509716
• Report Number: 3006425876-2020-01059
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: K103658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/11/2022
• Device Model Number: IPN046311
• Device Catalogue Number: JC-05400-B
• Device Lot Number: 71F20H2136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Date Manufacturer Received: 01/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1