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

Catalog Number ASK-05500-KM

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/04/2018

Event Type  malfunction  

Manufacturer Narrative

(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 user found leakage from the flat filter while in use.The catheter was removed and replaced.There was no patient injury.

Manufacturer Narrative

(b)(4).The customer reported the flat filter was leaking during use.The customer returned one snaplock adapter with clip, one flat filter, and one epidural catheter.The components were received connected.The returned components were visually examined with and without magnification.Visual examination of the returned snaplock adapter revealed that the snaplock appears typical with no observed defects or anomalies.Visual examination of the returned filter revealed that the filter appears typical with no observed defects or anomalies.Visual examination of the returned catheter revealed that the catheter appears typical but used.Adhesive material can be seen on the outer extrusion and biological material can be seen between the inner coils.No other defects or anomalies were observed.A manual flow test was performed on the returned filter by connecting a laboratory inventory syringe to the luer-slip end of the returned filter and manually injecting water.Water was observed exiting the luer-lock end of the filter.Then a closed snaplock adapter was connected to the luer-lock end while the laboratory inventory syringe was still connected to the luer-slip end.Water was once again injected into the filter.No leak was detected coming from the returned filter.A device history record review was performed on the flat filter with no relevant findings.A corrective action is not required at this time as the complaint could not be confirmed.No functional issues were found with the returned filter.The reported complaint of the filter leaking could not be confirmed based on the sample received.A device history record review was performed on the flat filter with no evidence to suggest a manufacturing related cause.The returned filter passed a manual leak test.There were no functional issues found with the returned filter.Teleflex will continue to monitor and trend related events.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7902949
• MDR Text Key: 121566097
• Report Number: 3006425876-2018-00631
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: ASK-05500-KM
• Device Lot Number: 71F18B2338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Date Manufacturer Received: 10/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1