MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD¿ ARTERIAL CANNULA WITH BD FLOWSWITCH¿ 20G X 45MM

Catalog Number 682245

Device Problems Break (1069); Kinked (1339)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/19/2015

Event Type  Injury  

Manufacturer Narrative

It was reported that the lot # for the reported device in unknown, but that it could potentially be 4287295.The information below is for the potential lot #: lot #: 4287295, medical device expiration date: 10/31/2019, device manufacture date: 10/14/2014.Pma / 510(k) #: there is no 510(k) for this device as it is manufactured outside the us and not sold in the us.It is unknown if a sample is available for evaluation, however two photos of the used device were returned for evaluation.An inspection of the photos compared to a photo of a non damaged device revealed that the broken catheter could have been cut by a sharp object.A review of the device history record revealed no irregularities for the potential lot # 4287295.Conclusion: an absolute root cause for this incident cannot be determined.Our quality engineer notes that there is no process in the manufacturing of the device that could have caused this nonconformance.Moreover, the manufacturing process has an automated vision inspection machine that rejects parts not meeting lie distance requirements and if the catheter break would have occurred in the manufacturing process, it would have been rejected by the automated vision inspection machine.

Event Description

It was reported that a 20g x 45mm bd¿ arterial cannula with bd flowswitch¿ was inserted into a patient while he/she was sleeping without any difficulties.The device was secured with steristrips, two cannula dressings, and a larger dressing over.There were no problems with monitoring or blood sampling for 24 hours.On removal before itu discharge the arterial cannula was found to be broken around 15mm from the hub and there were two significant kinks on the remaining part.The patient received an ultrasound and part of the cannula was confirmed to be in the patient's left radial artery.The cannula was removed by a vascular surgeon under local anesthesia in the itu.

• Brand Name: BD¿ ARTERIAL CANNULA WITH BD FLOWSWITCH¿ 20G X 45MM
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 5536675
• MDR Text Key: 41521571
• Report Number: 8041187-2016-00020
• Device Sequence Number: 1
• Product Code: NCP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 682245
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2016
• 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