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

Catalog Number 682245

Device Problem Leak/Splash (1354)

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

Event Date 08/11/2022

Event Type  malfunction  

Manufacturer Narrative

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 that the bd¿ arterial cannula experienced leakage.The following information was provided by the initial reporter: the patient had pneumonia and respiratory failure, and an indwelling arterial catheter was used for continuous invasive blood pressure monitoring.The arterial indwelling needle was successfully punctured, and blood extravasation occurred after the application was fixed.The inspection found that the buckle was broken.Another set of arterial indwelling needle was replaced and re-punctured, which increased the patient's pain and the risk of infection.

Event Description

It was reported that the bd¿ arterial cannula experienced leakage.The following information was provided by the initial reporter: the patient had pneumonia and respiratory failure, and an indwelling arterial catheter was used for continuous invasive blood pressure monitoring.The arterial indwelling needle was successfully punctured, and blood extravasation occurred after the application was fixed.The inspection found that the buckle was broken.Another set of arterial indwelling needle was replaced and re-punctured, which increased the patient's pain and the risk of infection.

Manufacturer Narrative

H6: investigation summary since no photos or samples displaying the reported condition of leakage were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15801702
• MDR Text Key: 307788583
• Report Number: 8041187-2022-00666
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/21/2022

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: 1357511
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2022
• Initial Date FDA Received: 11/15/2022
• Supplement Dates Manufacturer Received: 11/21/2022
• Supplement Dates FDA Received: 12/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2021
• 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