MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FLEXBLOCK KIT:ECHO CATH, 17GX5CM NS NDL; ANESTHESIA CONDUCTION KIT

Catalog Number FB-19605-K

Device Problems Kinked (1339); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device investigation has not been submitted at this time.Teleflex will continue to monitor and trend related events.

Event Description

Issue reported: the nursing team noticed the catheter had a kink in it when they removed it from the package but used it anyway.When the nursing team administered the initial bolus using the on-q pump, the catheter squirted medication out of the side of the catheter and the catheter was removed from the patient.There was no patient injury.

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 leaking.The customer returned one snaplock adapter, one epidural catheter, and lidstock.The snaplock adapter and catheter were received connected together.The returned components were visually examined with and without magnification.Visual examination of the returned snaplock adapter revealed that the snaplock adapter appears typical with no observed defects or anomalies.Visual examination of the returned catheter revealed that the catheter appears used as biological material can be seen on the inner coils.Microscopic examination of the catheter revealed the catheter is damaged at approximately 12cm ((b)(4)) from the proximal end.At the same location, a hole can be seen in the extrusion as well as the inner coils appear to be flattened.There is also a minor kink in the catheter at approximately 90mm from the proximal end.No other defects or anomalies were observed.A functional leak test was performed per mrq 000017 section 7.5 rev.7 using the returned catheter and snaplock adapter with the lab leak tester ((b)(4)).Other remarks: the proximal end of the catheter was inserted into the snaplock adapter until it bottomed out and the components were locked.The catheter was confirmed to be secured by tugging gently.The snaplock adapter was then connected to the lab leak tester and the pressure was increased to 10 psi to establish flow.The distal end of the catheter was then capped off and the pressure was increased to 25 psi for 30 seconds.A leak was detected coming from the same location where the catheter was damaged, which was revealed during the visual inspection.No other leaks were detected.A corrective action is not required at this time as the investigation shows no evidence to suggest a manufacturing related cause.All epidural catheters are tested for leaks at the time of manufacturing.A device history record review performed on the epidural catheter showed no evidence to suggest a manufacturing related cause.The leak was detected during use.Therefore, based on the condition of the sample received and the time of discovery indicate operational context caused or contributed to this event.(b)(4).

Event Description

Issue reported: the nursing team noticed the catheter had a kink in it when they removed it from the package but used it anyway.When the nursing team administered the initial bolus using the on-q pump, the catheter squirted medication out of the side of the catheter and the catheter was removed from the patient.There was no patient injury.

• Brand Name: FLEXBLOCK KIT:ECHO CATH, 17GX5CM NS NDL
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 6976302
• MDR Text Key: 90520085
• Report Number: 1036844-2017-00374
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: FB-19605-K
• Device Lot Number: 23F16K0140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/24/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1