MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION SET; ANESTHESIA CONDUCTION KIT

Model Number IPN046311

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 01/08/2020

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

It was reported that the theater room reported an incident with the device; rupture of catheter.A piece of catheter was found broken.Further information indicates: the anesthetist replied that it was a clear break as if the catheter had been pre-cut in this place (having already tried to cut one of these catheters it is almost impossible because of the material).The rupture was observed after the insertion when re-positioning the patient on the back.The place of the rupture is about 10-15cm from the filter snaplock and fortunately not on the intra-patient part, so no invasive procedure was necessary to remove the catheter.There were no serious negative consequences considering the location of the rupture.I could replace the filter on the remaining part but there could have been an infectious contamination.

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 broken during use.The customer returned one snaplock assembly, one flat filter and one epidural catheter (reference files (b)(4)).The returned components were visually examined with and without magnification.Visual examination of the returned snaplock assembly revealed that the snaplock appears typical with no observed defects or anomalies.Visual examination of the returned filter revealed that the filter appears typical with no observed defects or anomalies.Visual examination of the returned catheter revealed the proximal end is missing as the catheter appears to have been cut.No signs of stretching of the coil wire and extrusion can be seen at the point of separation at the likely proximal end.The distal end appears to be intact (reference files (b)(4)).The catheter appears to have been used as adhesive residue is present on the catheter body exterior as well as biological material between the inner coils.No other defects or anomalies were observed.A dimensional inspection was performed on the returned catheter using a ruler (10171599).The returned catheter extrusion measures approximately 75.2cm.This indicates at least 13.3cm of the extrusion is missing as the specification for the epidural catheter indicates that the proper extrusion length of an epidural catheter is 88.5-91.5 cm per graphic kz-05400-002 rev.9.Specifications per graphic kz-05400-002 rev.9 were reviewed as a part of this complaint investigation.The ifu for this kit, e-17019-110a; rev.02, 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 also 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 broke during use was confirmed based upon the sample received.The customer returned one catheter pieces that was separated at the extrusion.At least 13.3cm of the proximal end of the catheter was missing and there was no sign of stretching of the coil wire and extrusion at the point of separation.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.

Event Description

It was reported that the theater room reported an incident with the device; rupture of catheter.A piece of catheter was found broken.Further information indicates: the anesthetist replied that it was a clear break as if the catheter had been pre-cut in this place (having already tried to cut one of these catheters it is almost impossible because of the material).The rupture was observed after the insertion when re-positioning the patient on the back.The place of the rupture is about 10-15cm from the filter snaplock and fortunately not on the intra-patient part, so no invasive procedure was necessary to remove the catheter.There were no serious negative consequences considering the location of the rupture.I could replace the filter on the remaining part but there could have been an infectious contamination.

• Brand Name: EPIDURAL CATHETERIZATION SET
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9616607
• MDR Text Key: 180317394
• Report Number: 3006425876-2020-00079
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: K103658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/04/2021
• Device Model Number: IPN046311
• Device Catalogue Number: JC-05400-B
• Device Lot Number: 71F19H1056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2020
• Date Manufacturer Received: 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1