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

Catalog Number 682245

Device Problem Break (1069)

Patient Problem Swelling/ Edema (4577)

Event Date 07/27/2022

Event Type  malfunction  

Event Description

It was reported that 2 bd¿ arterial cannulas' tips broke off during use.The following information was provided by the initial reporter: "complaint came from hospital's medical intensive care unit department.During insertion, catheter tip was breaking.Patient began swelling.At that time, they have tried two cannula and both have the same problem.".

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6.Investigation summary: three photos were received by our quality team for evaluation.From the photos, needle through catheter was observed.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.In the assembly needle line, there is an online lie distance inspection.If the lie distance is out of specification, the part will be automatically rejected by the inspection system.As no sample was received for this complaint, a root cause cannot be determined.H3 other text : see h.10.

Event Description

It was reported that 2 bd¿ arterial cannulas' tips broke off during use.The following information was provided by the initial reporter: "complaint came from hospital micu department.During inserting, catheter tip was breaking.Patient got swealling.At that time they have tried two cannula and both have the same problem.".

• 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: 15254574
• MDR Text Key: 305374260
• Report Number: 8041187-2022-00476
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 682245
• Device Lot Number: 2020987
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2022
• 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