MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® FLUORIDE HEMOGARD¿ TUBE; BLOOD COLLECTON TUBE

Catalog Number 367922

Device Problems Component Missing (2306); Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/21/2018

Event Type  malfunction  

Manufacturer Narrative

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 there was no additive in the bd vacutainer® fluoride hemogard¿ tube prior to use.¿ no further information given.No reports of serious injury or medical intervention noted.

Manufacturer Narrative

Investigation summary: bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for tubes with missing additive with the incident lot was observed.Additionally, retention samples were selected from bd inventory for evaluation and upon completion, the issue relating to missing additive was not observed.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformance's during manufacturing of the product.Investigation conclusion: based on evaluation of the customer samples, the customer¿s indicated failure mode for tubes with missing additive with the incident lot was observed.Evaluation of the retain samples was also conducted and tubes with missing additive were not observed.Root cause description: based on the investigation, a root cause could not be determined.Rationale: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD VACUTAINER® FLUORIDE HEMOGARD¿ TUBE
• Type of Device: BLOOD COLLECTON TUBE
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7393697
• MDR Text Key: 104427796
• Report Number: 1917413-2018-00356
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903679225
• UDI-Public: 00382903679225
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K945952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 367922
• Device Lot Number: 7279859
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/22/2018
• Initial Date FDA Received: 04/03/2018
• Supplement Dates Manufacturer Received: 03/22/2018
• Supplement Dates FDA Received: 05/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2017
• 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): Other