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

Catalog Number JC-05400-B

Device Problems Fluid/Blood Leak (1250); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2019

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 since the previous complaint two other syringes are defective: one syringe has no resistance, sealing defect and the other has a leak.

Event Description

It was reported that since the previous complaint two other syringes are defective: one syringe has no resistance, sealing defect and the other has a leak.

Manufacturer Narrative

(b)(4).The customer reported there was no resistance due to a leak with the lor syringe.The customer returned one 10ml plastic lor syringe and lidstock (reference attached files (b)(4)the syringe was visually examined with and without magnification.Visual examination of the syringe revealed that the syringe appears typical with no observed defects or anomalies.Functional testing was performed on the returned syringe using the lab leak tester (c05176) per the parameters in amrq-000155 rev.4, section 7.2-positive pressure leakage.Water was aspirated into the syringe to the 8ml mark and the syringe was inverted to remove any air from the barrel.The tip of the syringe was then connected to the lab leak tester via tubing and pressure was applied.The syringe was tested at 10psi for 10 seconds.No leaks were detected.Water was removed from the syringe to the 2ml mark and the syringe was inverted to remove any air from the barrel.The tip of the syringe was then connected to the lab leak tester via tubing and pressure was applied.The syringe was tested at 10psi for 10 seconds.No leaks were detected.The returned lor syringe was compared to a lab inventory syringe by sliding the plunger into the barrel of the syringe.The resistance of the returned lor syringe was comparable to the lab inventory syringe.The luer end of the returned syringe was capped with the plunger completely inserted.An attempt to remove the plunger from the barrel was performed.The plunger seal snapped back when attempting to remove from the barrel.This was also performed with a lab inventory syringe with the same results.This indicates the plunger seal was creating a vacuum with no issues.No corrective action needed at this time since no functional issues were found with the returned lor syringe.The reported complaint of no resistance due to a leak could not be confirmed based on the sample received.The returned lor syringe passed functional testing including a leak test.Also, the returned lor syringe when compared to a lab inventory syringe had comparable resistance when sliding the plunger into the barrel of the syringe.A device history record review was performed on the lor syringe with no evidence to suggest a manufacturing related issue.There were no functional issues found with the returned sample.

Manufacturer Narrative

(b)(4).A device history record review was performed on the lor syringe with no relevant findings.A corrective action is not required at this time as the root cause for this complaint investigation could not be determined based upon the information provided and without the actual sample.Complaint verification testing could not be performed as no sample was provided for analysis.A device history record review was performed on the lor syringe with no evidence to suggest a manufacturing related cause.Therefore, the potential cause of the lor syringe having no resistance could not be determined based upon the information provided and without the sample.

Event Description

It was reported that since the previous complaint two other syringes are defective: one syringe has no resistance, sealing defect and the other has a leak.

• Brand Name: EPIDURAL CATHETERIZATION SET
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8708381
• MDR Text Key: 148313444
• Report Number: 3006425876-2019-00415
• 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,Followup
• Report Date: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2021
• Device Catalogue Number: JC-05400-B
• Device Lot Number: 71F19C0265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Date Manufacturer Received: 07/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1