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

Model Number IPN038182

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 06/22/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The catheter was found cut/separated in use.The patient was not agitated and the user was an experienced user with this device.Clinical consequences: the incident resulted in a delay in the treatment and pain management of the female patient.The device was removed and another one was used.

Event Description

The catheter was found cut/separated in use.The patient was not agitated and the user was an experienced user with this device.Clinical consequences: the incident resulted in a delay in the treatment and pain management of the female patient.The device was removed and another one was used.

Manufacturer Narrative

(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.The customer reported the catheter was found cut/separated during use.The customer returned one empty kit with a flat filter, snaplock assembly and two epidural catheter pieces.The returned filter and snaplock were received connected together (reference attached inp1900086252).The returned components were visually examined with and without magnification.Visual examination of the returned filter revealed the filter is used based on adhesive being on the outer body.Visual examination of the returned snaplock assembly revealed the snaplock appears typical with no observed defects or anomalies.Visual examination of the returned catheter pieces revealed on the likely most proximal piece, the extrusion and coil wire are slightly stretched at the likely distal end.The extrusion and coil wire on the likely most distal piece are also stretched at the point of separation at the likely proximal end.Also, both the proximal and distal ends of the returned catheter pieces appear to be intact.The catheter appears to have been used as biological material can be seen on the inner coils and adhesive can be seen on the outer extrusion.No other defects or anomalies were observed.The customer also provided a photo that appears to show a separated catheter.A dimensional inspection was performed on the catheter using a ruler (10171599).The proximal end catheter extrusion piece measures approximately 5.7cm.The distal end catheter piece measures approximately 86.3cm.Both catheter pieces combine to measure approxima tely 92cm.None of the catheter appears to be missing.However, with the coils and extrusion being slightly stretched, this is why the catheter is just outside of the specification of 88.5-91.5 cm per graphic kz-05400-030 rev.5.Specifications per graphic kz-05400-030 rev.5 were reviewed as a part of this complaint investigation.The ifu for this kit, e-17019-110a; rev.2, was reviewed as a part of this complaint investigation.The ifu warns the user, "never tug or quickly pull on catheter during removal from patient to reduce risk of catheter breakage.Do not apply additional tension on the catheter if catheter begins to stretch excessively.Reposition patient to open the vertebral interspaces and re-attempt removal if resistance is encountered or if catheter stretches excessively during removal." a corrective action is not required at this time as the condition of the sample received indicates unintentional user error caused or contributed to this event.The reported complaint of epidural catheter being found cut/separated during use was confirmed based upon the sample received.The customer returned two catheter pieces that were separated at the extrusion.None of the catheter was missing.At the point of separation, the extrusion is slightly stretched on the likely proximal and the likely distal pieces.The ifu for this product warns the user not to apply additional tension if the catheter begins to stretch as there is a risk for separation.Therefore, based upon the condition of the sample received, unintentional user error caused or contributed to this event.No further action is required at this time.

• Brand Name: EPIDURAL CATHETERIZATION SET
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• MDR Report Key: 12233000
• MDR Text Key: 263867629
• Report Number: 3006425876-2021-00697
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• PMA/PMN Number: K140110
• 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: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2022
• Device Model Number: IPN038182
• Device Catalogue Number: JC-05400-E
• Device Lot Number: 71F20L1179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• Initial Date Manufacturer Received: 07/16/2021
• Initial Date FDA Received: 07/27/2021
• Supplement Dates Manufacturer Received: 08/30/2021
• Supplement Dates FDA Received: 08/31/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2020
• 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