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

Catalog Number ASK-05500-KM

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2019

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 got disconnected from the snaplock adaptor during use on a patient.Therefore, the catheter was removed and all were replaced with a new kit.

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 and epidural catheter (reference files inp1900073845).The returned snaplock assembly was visually examined with and without magnification.The snaplock assembly appears typical with no defects or anomalies observed.Visual examination of the returned epidural catheter revealed that the catheter appears used.Biological material can be seen between the catheter coils and adhesive residue is present on the catheter body exterior.No other defects or anomalies were observed.A functional leak test was performed on the returned snaplock assembly and epidural catheter per (b)(4).The returned 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 (b)(4).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 (reference files (b)(4)).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 the returned epidural catheter and passed the functional tests performed including a spontaneous partial opening (spo) test.A device history record review was performed on the epidural catheter and snaplock assembly with no relevant findings.Therefore, based on function testing of the sample, no problem found with the returned snaplock assembly.

Event Description

It was reported that the catheter got disconnected from the snaplock adaptor during use on a patient.Therefore, the catheter was removed and all were replaced with a new kit.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9481817
• MDR Text Key: 179441694
• Report Number: 3006425876-2019-01058
• 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
• Type of Report: Initial,Followup
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/07/2021
• Device Catalogue Number: ASK-05500-KM
• Device Lot Number: 71F19F0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Date Manufacturer Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1