MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® GLASS CITRATE TUBE (13X75MM,4.5ML) LT BLUE BD HEMOGARD¿; BLOOD COLLECTION TUBE

Catalog Number 367704

Device Problem Detachment Of Device Component (1104)

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

Event Date 11/23/2016

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone #: (b)(6).Results: bd received a relative sample, from the customer, from the same indicated lot, for investigation.The sample was evaluated by simulated draw and the customer's indicated failure mode for stopper pull out with the incident lot was not observed.A review of the manufacturing records was completed 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 returned sample.

Event Description

It was reported that the caps from bd vacutainer® glass citrate tube (13x75mm,4.5ml) with the lt blue bd hemogard¿, keep popping off while in transport.No serious injury, blood to mucous membrane exposure or medical intervention was reported.

• Brand Name: BD VACUTAINER® GLASS CITRATE TUBE (13X75MM,4.5ML) LT BLUE BD HEMOGARD¿
• Type of Device: BLOOD COLLECTION TUBE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7095952
• MDR Text Key: 94266261
• Report Number: 9617032-2017-00335
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K013971
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/09/2017

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: 12/31/2017
• Device Catalogue Number: 367704
• Device Lot Number: 6172912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2016
• 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