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

Model Number IPN038182

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/04/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device investigation is pending.Teleflex will continue to monitor and trend related events.

Event Description

The report states: i would like to report an issue with the lor resistance in the epidural kit jc-05400-e (lot).The device in question is available at the pharmacy if needed.We had the same issue a few months back.

Event Description

The report states: i would like to report an issue with the lor resistance in the epidural kit jc-05400-e (lot).The device in question is avaialble at the pharmacy if needed.We had the same issue a few months back.

Manufacturer Narrative

Qn#(b)(4).A device history record review was performed on the lor syringe with no relevant findings.The customer reported issues with resistance for the lor syringe.The customer returned one empty kit with one 10ml plastic lor syringe.The syringe was visually examined.Visual examination of the syringe revealed that the syringe appears typical with no observed defects or anomalies.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 returned sample was returned to the supplier (preox) for leak testing.According to the supplier, no leak was found with the returned sample.A design history review was performed for part # kz-05501-002 as a part of this complaint investigation.Per eco-057562 (released 12-mar-2020), supplier (preox) made the following changes: optional component materials/mold locations: option 1: barrel: polypropylene - profax pf-535 lyondell-basell plunger: polypropylene 100-ga12 ineos olefins & polymers (molded at fleima plastic) blue stopper: silicone rubber (molded at et elastomer technik) option 2: barrel: polypropylene - profax pf-535 lyondell-basell plunger: polypropylene profax pf-531 lyondell-basell (molded at gpe) blue stopper: silicone rubber (molded at psilkon) lubricant: - the i.D.Of the barrel lubricated w/ medical grade silicone (polydimethylsiloxan) and amount will not exceed 0.25mg per sq centimeter.These effective changes did impact product design and material.It should be noted, the returned lor syringe was from the new design.The returned sample was returned to the supplier (preox) for functional testing.No issues were found with the returned sample.The reported complaint of issues with resistance for the lor syringe could not be confirmed based on the sample received.The returned lor syringe when compared to a lab inventory syringe had comparable resistance when sliding the plunger into the barrel of the syringe.The returned lor syringe was returned to the supplier (preox) for leak testing where no issues were found.A device history record review was performed on the lor syringe with no evidence to suggest a manufacturing related issue.Based on the supplier's results, no issues were found with the returned sample.

• Brand Name: EPIDURAL CATHETERIZATION SET
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10443245
• MDR Text Key: 204048288
• Report Number: 3006425876-2020-00732
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• PMA/PMN Number: K140110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/04/2020

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 Expiration Date: 05/12/2022
• Device Model Number: IPN038182
• Device Catalogue Number: JC-05400-E
• Device Lot Number: 71F20E1311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Initial Date Manufacturer Received: 08/04/2020
• Initial Date FDA Received: 08/24/2020
• Supplement Dates Manufacturer Received: 09/21/2020
• Supplement Dates FDA Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1