MAUDE Adverse Event Report: BECTON, DICKINSON & CO. 13X75 MM 2.0 ML BD VACUTAINER® TUBE WITH DIPOTASSIUM EDTA; BLOOD COLLECTION TUBE

Catalog Number 367840

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/21/2017

Event Type  malfunction  

Manufacturer Narrative

Results: a sample was not returned 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.(b)(4).

Event Description

It was reported that a stopper of a 13x75 mm 2.0 ml bd vacutainer® tube with dipotassium edta pulled out of the tube after use and blood spilled on the floor.There was no report of injury or medical intervention.

• Brand Name: 13X75 MM 2.0 ML BD VACUTAINER® TUBE WITH DIPOTASSIUM EDTA
• Type of Device: BLOOD COLLECTION 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: 6641987
• MDR Text Key: 77715990
• Report Number: 1917413-2017-00019
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981013
• 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
• Report Date: 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 367840
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/21/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other