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

Catalog Number JH-05500-J

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation at this time.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the user found slight crack-look damage on the lor, but continued to use it.At injection of the medical agent, the lor got broken.There was no reported patient injury.After this event occurred, the lor was dropped on the floor; the returned sample would be seriously damaged.

Manufacturer Narrative

Qn# (b)(4).A device history record review was performed on the kit and the lor syringe with no findings relevant to this complaint.The customer reported that the lor syringe broke during medical injection.The customer also indicated the syringe was dropped and damaged after use.The customer returned one glass lor syringe.The returned syringe was visually examined.Visual examination revealed that the tip is broken from the barrel.Also, the barrel is broken into several pieces.The packaging configuration for the kit was reviewed and the syringe is located in a tray cavity that is separated from other components.No corrective action is needed at this as the root cause for this complaint investigation was undetermined.The reported complaint of a broken lor syringe was confirmed based upon the sample received.The investigation found no evidence to suggest a manufacturing related cause therefore, the potential cause of this complaint could not be determined other remarks: based on the damaged observed to syringe and the information provided.

Event Description

It was reported that the user found slight crack-look damage on the lor, but continued to use it.At injection of the medical agent, the lor got broken.There was no reported patient injury.After this event occurred, the lor was dropped on the floor; the returned sample would be seriously damaged.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• 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: 7148519
• MDR Text Key: 95847227
• Report Number: 3006425876-2017-00588
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/12/2019
• Device Catalogue Number: JH-05500-J
• Device Lot Number: 71F17E2167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1