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

Catalog Number 682245

Device Problems Material Fragmentation (1261); Device Or Device Fragments Location Unknown (2590)

Patient Problem Numbness (2415)

Event Date 02/01/2016

Event Type  Injury  

Manufacturer Narrative

Date of event: it was reported that the incident occurred in (b)(6) 2016.The specific day of the month is unknown.Medical device expiration date: unknown.Pma / 510(k) #: there is no 510(k) for this device as it is manufactured outside the us and not sold in the us.Device manufacture date: unknown.Results: a sample is not available for evaluation.A review of the device history record could not be performed as a lot number was not provided for this incident.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.Udi #: (b)(4).

Event Description

It was reported upon removal of a bd¿ arterial cannula with bd flowswitch¿ 20g x 45mm, part of the cannula was missing and was believed to be retained in the patient's wrist.The patient had surgery to try and remove the missing piece but it could not be found.The patient was left with a small amount of numbness post surgery.It was also reported that scissors were not used when they removed the cannula but the initial reporter cannot be sure it was a smooth insertion or if the needle was rethreaded.

• 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 INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6122110
• MDR Text Key: 60747418
• Report Number: 8041187-2016-00080
• Device Sequence Number: 1
• Product Code: FOZ
• 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: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• 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?: No
• Date Manufacturer Received: 11/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention