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

Catalog Number 682245

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 12/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).Pma / 510(k) #: there is no 510(k) for this device as it is manufactured outside the us and not sold in the us.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the tip of a bd¿ arterial cannula with bd flowswitch¿ 20g x 45 mm broke off in a patient's right radial artery as it was being removed.The patient received a duplex scan and the broken catheter was removed surgically.

Manufacturer Narrative

Results: one used sample was returned for evaluation.A visual/microscopic inspection revealed a broken catheter that appeared to have been cut by a sharp object.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 6230127.A manufacturing review revealed no abnormalities with preventative maintenance, calibration, or equipment that could have influenced the customer's reported issue.Conclusion: although the returned sample confirmed a broken catheter, an absolute root cause for this incident cannot be determined.Additionally, our quality engineer notes that there is no process in the manufacturing facility that could have caused this type of defect and states that the defect most likely occurred outside of the manufacturing site.

• 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: 6431582
• MDR Text Key: 70781010
• Report Number: 8041187-2017-00033
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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,Followup
• Report Date: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 682245
• Device Lot Number: 6230127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2016
• 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