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

Model Number IPN048027

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2020

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 the lor syringe contained in the pdk set falls apart during use.

Manufacturer Narrative

(b)(4).A device history record review was performed based on potential lot numbers provided by the customer.A device history record review was performed on the lor nr fit syringe with no relevant findings.A review of design change history for kit ot19tkpss and part number kz-05501-002n was performed as a part of this investigation.No design changes have been made to this product in the past two years that would have led to this complaint.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 based on potential lot numbers provided by the customer.A device history record review was performed on the lor nr fit syringe with no relevant findings.Therefore, the potential cause of this complaint could not be determined based upon the information provided and without the sample.

Event Description

It was reported that the lor syringe contained in the pdk set falls apart during use.

• Brand Name: EPIDURAL CATHETERIZATION SET NRFIT
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9701820
• MDR Text Key: 180327690
• Report Number: 3006425876-2020-00170
• 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: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN048027
• Device Catalogue Number: OT19TKPSS
• Device Lot Number: UNKN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: N/A.