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

Catalog Number MP-17019-TKL

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 04/30/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device investigation is pending.Teleflex will continue to monitor and trend related events.

Event Description

The report states: i work in the biomed department at (b)(6).I follow up on patient safety reports here at the hospital.I have an epidural catheter that was involved in an incident that happened yesterday (b)(6).The tip broke off in the patient and i will need to contact the surgeon to see if they retrieved the tip.I would like to send the device to you for investigation.I have the broken device as well as an unopened device that we are hoping is from the same lot but we no longer have the packaging for the defective device.

Manufacturer Narrative

Qn#(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.The customer reported the catheter was difficult to remove.The customer returned one epidural catheter.The returned catheter was visually examined with and without magnification.Visual examination of the returned catheter revealed the extrusion and coil wire at the distal end appears to be slightly stretched and the distal tip is missing.The proximal side of the catheter appears to be intact as no damage was observed.Stretched coil wire separated from the returned catheter was also returned.The catheter appears to have been used as biological material between the inner coils.No other defects or anomalies were observed.The customer also returned a representative sample that included a snaplock assembly and epidural catheter.Visual examination of both components reveal they are both typical with no defects or anomalies observed.The customer also provided photos the shows a catheter that appear to be stretched.A dimensional inspection was performed on the returned catheter using a ruler (10171599).The returned catheter extrusion measures approximately 89.9cm.The extrusion and coils appear to be slightly stretched at the distal end of the catheter as well as the distal tip is missing.This is why the catheter is within the specification of 88.5-91.5 cm per graphic kz-05400-002 rev.09.The returned coil wire that was separated from the returned catheter measured approximately 13.5cm.Specifications per graphic kz-05400-021 rev.04 were reviewed as a part of this complaint investigation.The ifu for this kit, e-17019-109a; rev.7, 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.".The reported complaint of the catheter being difficult to remove was confirmed based upon the sample received.The catheter showed signs of stretching at the distal end and the distal tip was missing.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 and the observed evidence of the extrusion and coils stretching at the distal end, unintentional user error caused or contributed to this event.

Event Description

The report states: i work in the biomed department at (b)(6) in (b)(6).I follow up on patient safety reports here at the hospital.I have an epidural catheter that was involved in an incident that happened yesterday 4/30.The tip broke off in the patient and i will need to contact the surgeon to see if they retrieved the tip.I would like to send the device to you for investigation.I have the broken device as well as an unopened device that we are hoping is from the same lot but we no longer have the packaging for the defective device.

• Brand Name: EPIDURAL CATHETERIZATION KIT: 19 GA
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10101987
• MDR Text Key: 200834236
• Report Number: 1036844-2020-00152
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 05/01/2020

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 Expiration Date: 05/31/2021
• Device Catalogue Number: MP-17019-TKL
• Device Lot Number: 23F19M0176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2020
• Initial Date Manufacturer Received: 05/01/2020
• Initial Date FDA Received: 05/29/2020
• Supplement Dates Manufacturer Received: 06/17/2020
• Supplement Dates FDA Received: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1