MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT: 19 GA; ANESTHESIA CONDUCTION CATHETER

Model Number	IPN046495
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
The patient admitted for labor requesting labor epidural.During epidural placement: first attempt at l3/4 with crisp loss at 6cm.Dpe performed.25g whitacare needle through 17g tuohy.Clear csf return but patient endorses l paresthesia.No attempt made at threaded catheter.Redirected needle more midline, crisp loss at 6cm but unable to thread catheter.Tuohy needle pulled back to skin and redirected cephalad at l3/4.Crisp loss at 6cm.Threaded catheter but again patient endorsed l paresthesia with threading.Decision made to abort and try another level.Tuohy removed.Resistance met with pulling back catheter.Catheter removed with mild increase in traction but tip not intact about 1cm noted to be missing.Patient denied persistent paresthesia's and no foreign body noted at skin.Informed patient, labor rn and ob about retained foreign body.Consulted neurosurgery who recommended xr imaging of back after delivery of neonate.Ct abdomen showed 6mm l epidural density at l3-4, suspicious for retained epidural catheter tip.Neurosurgery evaluated and decided with patient that observation is the best course of action at this time.
Additional Manufacturer Narrative
Qn#(b)(4).A lot number was not provided.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the epidural catheter and epidural needle with no relevant findings.A design history review was performed for part# kz-05400-021 & kz-05500-007 as a part of this complaint investigation.There have been no material changes for this part during the last two years that could have led to this complaint.A corrective action is not required at this time as the root cause for this complaint investigation could not be determined based upon the information provided and without the actual sample.Complaint verification testing could not be performed as no sample was provided for analysis.A lot number was not provided.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the epidural catheter and epidural needle with no evidence to suggest a manufacturing related cause.Therefore, the potential cause of this complaint could not be determined based upon the information provided and without the sample.
Event or Problem Description
The patient admitted for labor requesting labor epidural.During epidural placement: first attempt at l3/4 with crisp loss at 6cm.Dpe performed.25g whitacare needle through 17g tuohy.Clear csf return but patient endorses l paresthesia.No attempt made at threaded catheter.Redirected needle more midline, crisp loss at 6cm but unable to thread catheter.Tuohy needle pulled back to skin and redirected cephalad at l3/4.Crisp loss at 6cm.Threaded catheter but again patient endorsed l paresthesia with threading.Decision made to abort and try another level.Tuohy removed.Resistance met with pulling back catheter.Catheter removed with mild increase in traction but tip not intact about 1cm noted to be missing.Patient denied persistent paresthesia's and no foreign body noted at skin.Informed patient, labor rn and ob about retained foreign body.Consulted neurosurgery who recommended xr imaging of back after delivery of neonate.Ct abdomen showed 6mm l epidural density at l3-4, suspicious for retained epidural catheter tip.Neurosurgery evaluated and decided with patient that observation is the best course of action at this time.

• Brand Name: EPIDURAL CATHETERIZATION KIT: 19 GA
• Common Device Name: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11307743
• Report Number: 1036844-2021-00022
• Device Sequence Number: 13744610
• Product Code: BSO
• UDI-Device Identifier: 10801902070194
• UDI-Public: 10801902070194
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2021

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
• Operator of Device: Health Professional
• Device Model Number: IPN046495
• Device Catalogue Number: MP-17019-TK
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/01/2021
• Supplement Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 03/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1