MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® SPECIALTY TUBES; DISCARD/NO ADDITIVE, HEMOGARD¿/ CLEAR; BLOOD COLLECTION TUBE

Catalog Number 366408

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 03/24/2017

Event Type  malfunction  

Manufacturer Narrative

Results: bd received samples from the customer facility for investigation.The samples were evaluated 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.

Event Description

It was reported that the stoppers of bd vacutainer® plus blood collection tube were coming off.No injury or medical intervention reported.

Manufacturer Narrative

The initial mdr was submitted with an inaccurate event description because the device brand name was incorrect.It has been corrected to read: "it was reported that the stoppers of bd vacutainer® specialty tubes; discard/no additive, hemogard¿/ clear, were coming off.No injury or medical intervention reported." the initial mdr was submitted with the incorrect device brand name.The correct brand name is bd vacutainer® specialty tubes; discard/no additive, hemogard¿/ clear.The initial mdr was submitted with a 510k number but this device is exempt and does not have a 510k associated with it.

Event Description

It was reported that the stoppers of bd vacutainer® specialty tubes; discard/no additive, hemogard¿/ clear, were coming off.No injury or medical intervention reported.

Manufacturer Narrative

The initial mdr was submitted with the incorrect medical device type.The correct type is fmh.

• Brand Name: BD VACUTAINER® SPECIALTY TUBES; DISCARD/NO ADDITIVE, HEMOGARD¿/ CLEAR
• Type of Device: BLOOD COLLECTION TUBE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7116836
• MDR Text Key: 95078957
• Report Number: 1024879-2017-00994
• Device Sequence Number: 1
• Product Code: FMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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,Followup,Followup
• Report Date: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 366408
• Device Lot Number: 6328897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2016
• 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