MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ARTERIAL CANNULA 20G/1.10MM X 45MM

Catalog Number 682245

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/05/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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/1.10mm x 45mm had foreign material.The following information was provided by the initial reporter, translated from (b)(6): "contamination of arterial cannula.".

Event Description

It was reported bd arterial cannula 20g/1.10mm x 45mm had foreign material.The following information was provided by the initial reporter, translated from german: "contamination of arterial cannula".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-09-06.H6: investigation summary: three photos and one sample were received by our quality team for evaluation.From the photo, foreign matter was observed on the floswitch housing.From the sample, foreign matter is observed on the luer id of the floswitch housing.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.The sample was sent for fourier transform infrared spectroscopy (ftir) testing.The ftir was unable to identify the foreign matter material.Although the ftir was not able to identify the type of foreign matter, the arterial cannula assembly process was reviewed to identify areas in contact with the luer id.As the foreign matter is on the surface of the id wall, it was most likely introduced by pins that was inserted into the luer area during the assembly needle (an) production.Three areas (collapse valve insert station, guide bush insert station, and guide bush check station) were identified as the outermost diameter of the pin insert is nearer to the id wall of the floswitch housing luer.When the outer diameter is nearer to the luer¿s id wall, there may be a chance if the pin has foreign matter, it may transfer to the id wall.While there is a cleaning in this area during daily housekeeping, the cleaning might not be effective during housekeeping.A visual check on the pins will now be performed after they are cleaned to ensure cleanliness.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
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12424966
• MDR Text Key: 271300382
• Report Number: 8041187-2021-00799
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/14/2021

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: 0325947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/05/2021
• Initial Date FDA Received: 09/03/2021
• Supplement Dates Manufacturer Received: 10/14/2021
• Supplement Dates FDA Received: 11/09/2021
• 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