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

Model Number IPN046313

Device Problem Fluid/Blood Leak (1250)

Patient Problems Headache, Lumbar Puncture (2186); No Consequences Or Impact To Patient (2199)

Event Date 01/24/2020

Event Type  Injury  

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 lor syringe is leaking water.The lot involved was mainly the lot #71f19g1938 but we cannot provide the exact number of complaints with 71f19g1938 and lot #71f19g2461 because the lot number is not on the syringe.10 patients were involved and faced this incident.Clinical consequences: the epidural space is difficult to locate because of the lack of resistance.Out of the 10 patients involved there were one or two dura mater breach.So, no serious injury but few blood patches were applied with efficiency.Further information indicates that 4, around 5 patients had a blood patch performed.

Manufacturer Narrative

(b)(4).A device history record review was performed based on a potential lot number (71f19g1938) provided by the customer.Lot number 71f19g2461 provided by the customer was not a valid lot in sap.A device history record review was performed on the lor syringe with no relevant findings.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 without the actual sample.Complaint verification testing could not be performed as no sample was provided for analysis.A device history record review was performed based on a potential lot number provided by the customer.A device history record review was performed on the lor syringe with no evidence to suggest a manufacturing related issue.Therefore, the potential cause of this complaint could not be determined based upon the information provided and without the sample.

Event Description

It was reported that the lor syringe is leaking water.The lot involved was mainly the lot #71f19g1938 but we cannot provide the exact number of complaints with 71f19g1938 and lot #71f19g2461 because the lot number is not on the syringe.10 patients were involved and faced this incident.Clinical consequences: the epidural space is difficult to locate because of the lack of resistance.Out of the 10 patients involved there were one or two dura mater breach.So, no serious injury but few blood patches were applied with efficiency.Further information indicates that 4, around 5 patients had a blood patch performed.

• Brand Name: EPIDURAL CATHETERIZATION SET
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 9695304
• MDR Text Key: 188541774
• Report Number: 3006425876-2020-00126
• 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: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN046313
• Device Catalogue Number: JC-05400-DCS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention