MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FLEXTIP PLUS EPIDURAL CATHETER; ANESTHESIA CONDUCTION CATHETER

Catalog Number EC-05500

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2018

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 catheter dislodged from the snaplock on the patient side, requiring a spinal and c/s instead of just topping up the catheter.

Manufacturer Narrative

(b)(4).A device history record review was performed on the epidural catheter and snaplock assembly with no relevant findings.The customer reported that the snaplock assembly disconnected from the catheter.The customer returned one snaplock assembly, one non teleflex flat filter, and lidstock (reference attached files (b)(4)).The returned snaplock assembly was visually examined with and without magnification.The snaplock assembly appears typical with no defects or anomalies observed.A functional leak test was performed on the returned snaplock assembly per amrq-000017 section 7.5; rev.7.A lab inventory epidural catheter was inserted from the proximal end into the returned snaplock assembly until it bottomed out and the snaplock assembly was closed.The components were confirmed to be secured by tugging gently.The snaplock assembly was connected to the lab leak tester (c05176) and the pressure was increased to 10 psi to establish flow.The distal end of the catheter was capped off and the pressure was increased to 25 psi for 30 seconds.No leaks were detected and the components remained secured.A functional spontaneous partial opening (spo) test was then performed per amrq-000017 section 7.7; rev 7.The proximal end of the epidural catheter was re-inserted into the snaplock assembly until it bottomed out and the snaplock assembly was locked.The components were confirmed to be secured by tugging gently on the catheter.The components were then left to sit for 72 hours in the locked position.After 72 hours, the snaplock assembly was confirmed to have remained securely locked with the catheter inserted.No functional issues were found.The reported complaint of the snaplock assembly disconnecting from the catheter could not be confirmed through functional testing of the returned snaplock assembly.The snaplock assembly was secured to a lab inventory epidural catheter and passed the functional tests performed including a spontaneous partial opening (spo) test.There was no problem found with the returned snaplock assembly.

Event Description

It was reported that the catheter dislodged from the snaplock on the patient side, requiring a spinal and c/s instead of just topping up the catheter.

• Brand Name: FLEXTIP PLUS EPIDURAL CATHETER
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8117062
• MDR Text Key: 128873052
• Report Number: 3006425876-2018-00778
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/23/2018

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: 03/08/2020
• Device Catalogue Number: EC-05500
• Device Lot Number: 71F18C0414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2018
• Initial Date Manufacturer Received: 11/23/2018
• Initial Date FDA Received: 11/29/2018
• Supplement Dates Manufacturer Received: 01/07/2019
• Supplement Dates FDA Received: 01/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1