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

Catalog Number AK-05503

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Reported issue: plastic catheter tip broke off on withdrawal from patient's spine leaving approximately 5-6 cm piece inside the epidural space.Per (risk manager) patient in active labor underwent an epidural insertion.Upon withdrawal from the spine, the plastic catheter tip broke off leaving an approximately 5-6cm piece inside the epidural space.Patient examined by neurology np and anesthesiologist.Np, neurologist and anesthesiologist concluded risk of removal outweighed the potential for harm by leaving it in place.Patient denies and weakness or change in sensation of the lower extremities.

Event Description

Reported issue: plastic catheter tip broke off on withdrawal from patient's spine leaving approximately 5-6 cm piece inside the epidural space.Per (risk manager) patient in active labor underwent an epidural insertion.Upon withdrawal from the spine, the plastic catheter tip broke off leaving an approximately 5-6cm piece inside the epidural space.Patient examined by neurology np and anesthesiologist.Np, neurologist and anesthesiologist concluded risk of removal outweighed the potential for harm by leaving it in place.Patient denies and weakness or change in sensation of the lower extremities.

Manufacturer Narrative

(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.The ifu for this kit, e-17019-109a; rev.07, was reviewed as a part of this complaint investigation.The ifu warns the end user, "never advance catheter more than 5 cm beyond the needle tip.Advancing catheter more than 5 cm increases the likelihood of catheter-related complications." 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 a potential root cause could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed on the epidural catheter with no evidence to indicate a manufacturing related issue.Therefore, the potential cause of the catheter breaking could not be determined based upon the information provided and without a sample.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 10785956
• MDR Text Key: 214578350
• Report Number: 1036844-2020-00293
• 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: other
• Type of Report: Initial,Followup
• Report Date: 10/20/2020

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 Catalogue Number: AK-05503
• Device Lot Number: 23F20F1029
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/20/2020
• Initial Date FDA Received: 11/04/2020
• Supplement Dates Manufacturer Received: 12/04/2020
• Supplement Dates FDA Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 32 YR