MAUDE Adverse Event Report: TELEFLEX MEDICAL EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION CATHETER

Model Number IPN924967

Device Problem Physical Resistance/Sticking (4012)

Patient Problems Cerebrospinal Fluid Leakage (1772); Headache (1880); Needle Stick/Puncture (2462); Unspecified Tissue Injury (4559)

Event Date 01/19/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Reported event: there was no loss of resistance.The syringe was locked.A dura puncture occurred and a blood patch was performed.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

Reported event: there was no loss of resistance.The syringe was locked.A dura puncture occurred and a blood patch was performed.

Event Description

Reported event: there was no loss of resistance.The syringe was locked.A dura puncture occurred and a blood patch was performed.

Manufacturer Narrative

(b)(4).It was reported "when prepping the kit, i filled the loss of resistance syringe with the sterile ns and worked the plunger up and down and twisted it side to side before ever using it on the patient.It seemed to be completely normal.I proceeded with epidural placement on a thin patent with normal anatomy and was not feeling loss of resistance at a depth i expected to.I advanced farther very slowly and never got loss.I stopped, knowing something wasn't right.I then backed out and attempted again to achieve loss.Not feeling it again at a depth i expected to, i then disengaged the syringe from the tuohy needle, noting csf return through the tuohy.At this point i pulled the tuohy out and inspected the glass syringe, noting it to be completely frozen; it was locked.There would never have been a loss of resistance to feel because this syringe was never going to move.I informed the patient what had happened and even showed her the syringe.I told her that she was at a much greater risk of getting a headache because of this.Because of this faulty syringe i punctured the dura of a young healthy woman who was just about to give birth 2 times with a 17-gauge needle.She ended up with a nasty dura puncture headache and had to receive a blood patch." no further medical intervention required.It was reported that "there was no injury", patient condition reported as fine after blood patch.Corrected data: section e.Initial reporter was not a medical professional.Added contact information for initial reporter.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 16386950
• MDR Text Key: 309677113
• Report Number: 1036844-2023-00010
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 10801902209532
• UDI-Public: 10801902209532
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN924967
• Device Catalogue Number: AK-05503
• Device Lot Number: OT #13F22J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2023
• 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: Initial
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED; NONE REPORTED
• Patient Outcome(s): Required Intervention
• Patient Sex: Female