MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ARTERIAL CANNULA

Catalog Number 682245

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/29/2021

Event Type  Injury  

Manufacturer Narrative

Device expiration date: unknown.Device manufacture date: unknown.Investigation summary: no photos or samples were available to the quality team for evaluation, therefore, the nonconformance could not be verified.A device history record could not be evaluated as the lot number is unknown.The arterial cannula tube draw machine was reviewed and the machine parts that contact the catheter tubing are the machine grippers.However, the machine grippers have a round flat surface with no sharp edges that could cause part-off in the catheter tubing.The arterial cannula assembly machine was also reviewed.There is an automated vision inspection machine at the arterial cannula assembly machine, and it will auto reject any parts not meeting the lie distance requirement.If the catheter tubing is broken, its lie distance would most likely have failed and will automatically be rejected by the line.Based on the quality team's investigation, the root cause of this incident cannot be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: there is no batch number provided for this complaint.If there is a batch number provided, the dhr can be reviewed to check if there was any qn raised for broken catheter in the assembly needle batch used to produce this complaint batch.No sample was received for this complaint.If there was sample received, the part off area can be investigated to determine the cause of the broken catheter.The complaint will be re-opened when there is sample received.The complaint trend will be monitored and tracked.

Event Description

It was reported that the bd arterial cannula experienced device damage while still considered operable.A portion of the cannula remained embedded within the patient's artery after device removal.Patient underwent "exploration and removal of foreign matter" surgical intervention.The following information was provided by the initial reporter: on removal of the flow switch, the nurse noticed that approximately 5cm of the catheter remained in the patients artery.The patient returned to theatre for 'exploration and removal of foreign object' surgery.

• Brand Name: BD ARTERIAL CANNULA
• Type of Device: ARTERIAL CANNULA
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12573750
• MDR Text Key: 274743775
• Report Number: 8041187-2021-00884
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 682245
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention