MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® SST¿ TUBES BD HEMOGARD¿/GOLD; BLOOD COLLECTION TUBE

Catalog Number 367986

Device Problem Detachment Of Device Component (1104)

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

Event Date 04/13/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Results: bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for stopper pop off with the incident lot was observed.A review of the manufacturing records was completed for the incident lot and no issues were identified.Conclusion: the potential root cause(s) were identified as excessive lubricant on the stoppers.Bd has initiated a capa (b)(4) to document further investigation and root cause of this product issue.

Event Description

It was reported that bd vacutainer® sst¿ tubes bd hemogard¿/gold had stoppers that would come off when centrifuged.No serious injury, no medical intervention.No mucous membrane exposure reported.

• Brand Name: BD VACUTAINER® SST¿ TUBES BD HEMOGARD¿/GOLD
• 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: 7097096
• MDR Text Key: 94968790
• Report Number: 1024879-2017-01026
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903679867
• UDI-Public: 00382903679867
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K023075
• 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: 11/16/2017

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: 10/31/2017
• Device Catalogue Number: 367986
• Device Lot Number: 6305648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2016
• 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