MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC EPIDURAL CATHETERIZATION COMPONENT; CATHETER, CONDUCTION, ANESTHETIC

Catalog Number MP-00019-NRF

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/06/2022

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 medical agent was found leaking from the catheter during placement.Therefore, it was removed and replaced with a new one.Additional information indicates that there was a hole in the catheter.

Manufacturer Narrative

(b)(4).The customer reported the catheter was leaking.The customer returned one snaplock assembly nrfit and one epidural catheter.The returned components were received connected together.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 and adhesive material can be seen on the outer extrusion.Microscopic examination of the catheter revealed the catheter is damaged at approximately 16cm from the proximal end.The extrusion appears to be flattened and has a hole.No other damage was 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.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 coming from the same location where the catheter has a hole at approximately 16cm from the proximal end, which was revealed during the visual inspection.No other leaks were detected.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.The reported complaint of the catheter leaking was confirmed based on evaluation of the sample received.During the functional inspection, the returned epidural catheter was confirmed to leak from where the catheter was damaged at approximately 16cm from the proximal end.All epidural catheters are 100% tested for leaks at the time of manufacturing.A lot number was not provided.A device history record review was performed based upon a potential lot number.A device history record review was performed on the epidural catheter 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.

Event Description

It was reported that medical agent was found leaking from the catheter during placement.Therefore, it was removed and replaced with a new one.Additional information indicates that there was a hole in the catheter.

• Brand Name: EPIDURAL CATHETERIZATION COMPONENT
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 16034841
• MDR Text Key: 306815289
• Report Number: 3006425876-2022-01154
• Device Sequence Number: 1
• Product Code: BSO
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2022

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 Catalogue Number: MP-00019-NRF
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 01/20/2023
• Supplement Dates FDA Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: NONE REPORTED.; NONE REPORTED.