MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION KIT

Catalog Number JC-05400-B

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 06/01/2019

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 it was observed that the syringe has changed.The staff does not have the same sensation during insertion of the epidural.There is a lack of resistance like a leak at the level of the plunger.A blood patch had to be applied on the 2 patients.With post-epidural pain.One of the patients had to come back to the hospital.She had more pain.Another blood patch had to be applied on her.

Event Description

It was reported that it was observed that the syringe has changed.The staff does not have the same sensation during insertion of the epidural.There is a lack of resistance like a leak at the level of the plunger.A blood patch had to be applied on the 2 patients.With post-epidural pain.One of the patients had to come back to the hospital.She had more pain.Another blood patch had to be applied on her.

Manufacturer Narrative

Qn#(b)(4).Report number is retracted as it was entered and submitted in err.There was not a third device involved in the reported event.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8740177
• MDR Text Key: 149377529
• Report Number: 1036844-2019-00825
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: JC-05400-B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention