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

Model Number IPN046629

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 06/28/2021

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

Anesthesia tech notified me that multiple crnas and mds have experienced issues with catheter not threading through needle once epidural space has been located requiring resticking.

Event Description

Anesthesia tech notified me that multiple crnas and mds have experienced issues with catheter not threading through needle once epidural space has been located requiring resticking.

Manufacturer Narrative

(b)(4).A device history record review was performed on the epidural catheter and needle with no relevant findings.The customer reported the catheter would not thread.The customer returned one sealed representative kit from lot # 23f21c0175 for i nvestigation (reference attached files (b)(4)).The actual complaint sample was not returned.The returned kit was opened and the epidural needle and epidural needle were removed and visually examined with and without magnification.Visual examination of the returned needle revealed that the needle appears typical.The needle bevel appears polished and smooth with no observed burrs.The needle cannula appears typical.No defects or anomalies were observed.Visual examination of the returned catheter revealed the catheter appears typical with no defects or anomalies observed.A dimensional inspection was performed on the returned epidural needle.The inner diameter (id) measured 0.046in (1.17mm) (pin gauge: ref-003131), which is within specification of 1.17mm per graphic kz-05500-007; rev 9.A dimensional inspection was performed on the returned epidural.The outer diameter (od) of the returned catheter measured 1.03mm (caliper: ref-003210) which is within the specification of a maximum of 1.115mm per graphic kz-05400-030; rev 5.A functional test was performed by attempting to thread the returned catheter through the returned epidural needle.The catheter was threaded at the distal end and would thread through the epidural needle with no resistance met.A drag test was performed per pip-013; rev 5 using the returned components and a weight (ref-002579).The catheter could thread through the returned needle with no resistance met.The components passed the drag test.Specifications per graphic kz-05500-007; rev 9 and kz-05400-030; rev 5 were reviewed as a part of this complaint investigation.A design history review was performed for part # kz-05500-007 and kz-05400-030 as a part of this complaint investigation.There have been no material changes for these parts during the last two years that could have led to this complaint.A corrective action is not required at this time as the complaint could not be confirmed based upon the information provided and without the actual complaint sample.The representative sample received was visually inspected and functionally tested with no issues.The reported complaint of the catheter unable to thread could not be confirmed based on the sample received.The actual complaint sample was not returned; only a representative sample was received.The returned catheter could be threaded through the returned needle with no resistance met.The returned components passed a functional drag test, and the returned needle id and returned catheter od were found to be within specification.A device history record review was performed on the epidural catheter and needle with no relevant findings.Therefore, a potential root cause could not be determined based upon the information provided or without the actual complaint sample.No further action is required at this time.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 12158273
• MDR Text Key: 261274956
• Report Number: 1036844-2021-00134
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 50801902013694
• UDI-Public: 50801902013694
• Combination Product (y/n): N
• PMA/PMN Number: K140110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN046629
• Device Catalogue Number: SJ-05501
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Date Manufacturer Received: 08/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1