MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® K2EDTA PLUS BLOOD TUBE LAVENDER BD HEMOGARD¿; EDTA SERUM TUBES

Catalog Number 367856

Device Problem Component Falling (1105)

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

Event Date 08/26/2015

Event Type  malfunction  

Manufacturer Narrative

Results: bd received 10 samples from the same incident lot from the customer facility for investigation.Samples returned to bd did not confirm the customers' indicated failure mode of loose stoppers/leakage.A review of the manufacturing records was completed for the incident lot and no issues were identified.Conclusion: bd was not able to confirm the customer¿s indicated failure mode because the defect was not evident in the testing of the 10 returned samples for stopper creep or leakage.

Event Description

It was reported that stopper caps are falling off and are not secure on bd vacutainer® (b)(4) plus plastic whole blood tubes (13x75mm,3.0 ml) with the lavender bd hemogard¿ closures.No serious injury, blood to mucous membrane exposure or medical intervention was reported.

• Brand Name: BD VACUTAINER® K2EDTA PLUS BLOOD TUBE LAVENDER BD HEMOGARD¿
• Type of Device: EDTA SERUM TUBES
• 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: 7081262
• MDR Text Key: 94249356
• Report Number: 1917413-2017-00191
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903678563
• UDI-Public: 00382903678563
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K981013
• 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: 11/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2016
• Device Catalogue Number: 367856
• Device Lot Number: 5014806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2015
• 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