MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC EPIDURAL CATHETERIZATION KIT NRFIT

Catalog Number ASK-05500-NRON

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/04/2022

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).The device has not been returned for investigation.

Event Description

The medical agent was found leaking from the connection between the catheter and the snaplock adaptor during use on a patient.It occurred to 2 kits in succession.The user replaced the catheter and the snaplock adaptor with a new kit of the same lot, by which leak did not occur.

Event Description

The medical agent was found leaking from the connection between the catheter and the snaplock adaptor during use on a patient.It occurred to 2 kits in succession.The user replaced the catheter and the snaplock adaptor with a new kit of the same lot, by which leak did not occur.

Manufacturer Narrative

Qn# (b)(4).A device history record review was performed on the epidural catheter and snaplock assembly with no relevant findings.The customer reported the there was a leak between the catheter and the snaplock.The customer returned one flat filter nrfit, one snaplock assembly nrfit, and an epidural catheter.The returned components were received connected together (reference attached files (b)(4).The returned components were visually examined with and without magnification.Visual examination of the returned snaplock assembly revealed the snaplock 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.After functional testing was performed, microscopic examination revealed the catheter is damaged at approximately 15mm (ruler: ref-003192) from the proximal end.The extrusion appears to have cuts/holes.No other defects or anomalies were observed.Functional inspection was performed on the returned sample.A functional leak test was performed per amrq-000017 section 7.5 rev.10, using the returned catheter and snaplock assembly with the lab leak tester (ref-(b)(4).The proximal end of the catheter was inserted into the snaplock assembly until it bottomed out and the components were locked.The catheter was confirmed to be secured by tugging gently.The snaplock assembly 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 between the catheter and snaplock connection.The test was repeated using the returned snaplock assembly and lab inventory epidural catheter.No leak was detected between the catheter and snaplock connection, indicating that there are no leak issues with the returned snaplock assembly.The test was repeated again using a lab inventory snaplock assembly and the returned epidural catheter.A leak was detected between the catheter and snaplock connection, indicating the leak was from the returned catheter.Microscopic examination revealed the catheter is damaged at approximately 15mm from the proximal end as the extrusion appears to have cuts/holes.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.The leak was detected during use.Therefore, based on the condition of the sample received and the time of discovery indicate unintentional user error caused or contributed to this event.The reported complaint of a leak between the catheter and snaplock was confirmed based on the sample received.During the functional inspection, the returned epidural catheter was confirmed to leak from where the catheter was damaged at approximately 15mm from the proximal end.All epidural catheters are 100% tested for leaks at the time of manufacturing.A device history record review was performed on the epidural catheter and snaplock assembly with no evidence to suggest a manufacturing related issue.The leak was detected during use.Therefore, based on the time of discovery and the condition of the sample received, unintentional user error caused or contributed to this event.No further action is required at this time.

• Brand Name: EPIDURAL CATHETERIZATION KIT NRFIT
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 14468858
• MDR Text Key: 296049244
• Report Number: 3006425876-2022-00522
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/15/2022
• Device Catalogue Number: ASK-05500-NRON
• Device Lot Number: 71F20K1216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1