MAUDE Adverse Event Report: BECTON DICKINSON BD¿ARTERIAL CANNULA; INTRAVENOUS INFUSION DEVICE

Catalog Number 682245

Device Problem Fracture (1260)

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

Event Date 07/06/2016

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.

Event Description

It was reported that the suspect device was discovered to be "fractured" when the dressing was removed in the recovery room.No medical intervention was rendered at that time, and none has been reported; however, "the patient requires an appointment in another trust (qmc) for plan for removal as unable to undertake the procedure at this trust.".

Manufacturer Narrative

Bd corporate headquarters in (b)(6) has been listed as the manufacturing site of this device; the actual manufacturing site (b)(6) is an oem.

Manufacturer Narrative

A sample is not available for evaluation.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 204038.Conclusion: without a sample, an absolute root cause for this incident cannot be determined.

• Brand Name: BD¿ARTERIAL CANNULA
• Type of Device: INTRAVENOUS INFUSION DEVICE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 5836689
• MDR Text Key: 50845651
• Report Number: 2243072-2016-00023
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: 682245
• Device Lot Number: 204038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention