MAUDE Adverse Event Report: BECTON, DICKINSON & CO. 13 X 75 MM X 4.5 ML BD VACUTAINER® GLASS PLASMA TUBE. LT. BLUE BD HEMOGARD¿; BLOOD COLLECTION TUBE

Catalog Number 369714

Device Problems Detachment Of Device Component (1104); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2016

Event Type  malfunction  

Manufacturer Narrative

Results: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.A review of the manufacturing records was completed for the incident lot and no issues were identified.Bd has initiated a capa to document further investigation and root cause(s) of this product issue.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.Refer to (b)(4).

Event Description

It was reported that after opening the 13 x 75 mm x 4.5 ml bd vacutainer® glass plasma tube.Lt.Blue bd hemogard¿, the stopper popped off.The loose stopper could cause exposure to biological material.No serious injury or medical intervention reported.

• Brand Name: 13 X 75 MM X 4.5 ML BD VACUTAINER® GLASS PLASMA TUBE. LT. BLUE BD HEMOGARD¿
• 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: 7096211
• MDR Text Key: 94853850
• Report Number: 1917413-2017-00414
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903697144
• UDI-Public: 00382903697144
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K945952
• 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: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: 369714
• Device Lot Number: 5336909
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other