MAUDE Adverse Event Report: BD ARTERIAL CANNULA 20G/1.10MM X 45MM

Catalog Number 682245

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem Insufficient Information (4580)

Event Date 08/05/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used.Initial reporter zip: (b)(6).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported bd arterial cannula 20g/1.10 mm x 45 mm kinked during use.The following information was provided by the initial reporter, translated from dutch: "the product kinked very quickly and frequently after being placed on the patient, making it unusable.".

Event Description

It was reported bd arterial cannula 20g/1.10mm x 45mm kinked during use.The following information was provided by the initial reporter, translated from dutch: "the product kinked very quickly and frequently after being placed on the patient, making it unusable.".

Manufacturer Narrative

H6: investigation summary, one sample was received by our quality team for evaluation.Multiple kink locations were observed on the catheter tubing.One location was observed with pierce through.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.If there is a kink on the catheter tubing during assembly, the cannula would most likely have pierced through the catheter tubing.There is an online inspection for lie distance on the arterial cannula assembly line.If there are any catheter pierce through in the catheter tubing, the lie distance would have likely failed, and it would be rejected by the online inspection system.A simulation was carried out by intentionally piercing the catheter tubing.The pierced through area is observed under the scope.The pierced through area seen on the simulated sample is observed to be similar to the pierced through the area of the returned customer sample.From the quality team¿s investigation, the kink / bent and pierced through could have happened outside the manufacturing process.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD ARTERIAL CANNULA 20G/1.10MM X 45MM
• Type of Device: NA
• MDR Report Key: 12421961
• MDR Text Key: 271269392
• Report Number: 8041187-2021-00797
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/15/2021

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: Other
• Device Catalogue Number: 682245
• Device Lot Number: 0325257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Initial Date Manufacturer Received: 08/05/2021
• Initial Date FDA Received: 09/03/2021
• Supplement Dates Manufacturer Received: 09/15/2021
• Supplement Dates FDA Received: 09/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1