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

Catalog Number 369714

Device Problems Fogging (1253); Split (2537)

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

Event Date 12/28/2016

Event Type  malfunction  

Manufacturer Narrative

Results: bd pas received(b)(4) samples from the customer facility for investigation.The customer samples were evaluated and the customer¿s indicated failure mode of ¿draw volume - underfill¿ and "split tubes" with the incident lot was not observed as all samples met the required specifications.Water fill testing was conducted on the customer samples and no defects related to draw volume were observed.The manufacturing records were reviewed for the incident lot and no issues were identified.Conclusion: bd was unable to duplicate or confirm the customer¿s indicated failure mode because the defect was not evident in the testing of the customer samples.One root cause of the damage that is between stopper and the label is a j crack.It can happen during the forming process.This occurs at the point where the glass is being heated to be cut.The reason that j cracks occur is due to the quality of the cane glass or if the heat is too high.If the tube gets a j crack when the stopper/shield is assembled onto the tube it can cause the tube to break.

Event Description

It was reported that the bd vacutainer® glass plasma tube lt.Blue bd hemogard¿ tubes have stopped filling and two have split in the area under the cap and above the top of the label.The tubes are very cold to touch and have a larger amount of "foggy area" inside them.No serious injury or medical intervention reported.

• Brand Name: 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: 7115162
• MDR Text Key: 95074053
• Report Number: 1917413-2017-00606
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903697149
• UDI-Public: 50382903697149
• 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
• Report Date: 12/12/2017

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: 04/30/2017
• Device Catalogue Number: 369714
• Device Lot Number: 5272777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/28/2016
• Initial Date FDA Received: 12/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2015
• 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