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

Catalog Number MP-00019-S

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2019

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 in a ward.Therefore, the catheter was removed, and all the kit were replaced with a new one.The user would like to know what caused this issue; that the device had a defect or that the catheter was not inserted into the snaplock fully enough.

Manufacturer Narrative

(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 snaplock assembly with no relevant findings.The customer reported that the snaplock assembly disconnected from the catheter.The customer returned one snaplock assembly (reference 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.It should be noted, the insertion of the catheter into the snaplock assembly did have some resistance; however, the catheter would insert fully.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 (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.Although some resistance was met when inserting the catheter into the snaplock, the snaplock assembly was secured to a lab inventory epidural catheter and passed the functional tests performed including a spontaneous partial opening (spo) test.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 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 in a ward.Therefore, the catheter was removed , and all the kit were replaced with a new one.The user would like to know what caused this issue; that the device had a defect or that the catheter was not inserted into the snaplock fully enough.

• Brand Name: EPIDURAL CATHETERIZATION COMPON
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9415941
• MDR Text Key: 179263560
• Report Number: 3006425876-2019-00987
• 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: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MP-00019-S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2019
• Date Manufacturer Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: N/A.