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 04/03/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Results: bd had not received samples, but photos were provided by the customer facility for investigation.The photos 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: without a sample, an absolute root cause for this incident cannot be determined.Bd has initiated a capa (b)(4) to document further investigation and root cause(s) of this product issue.

Event Description

It was reported that the bd vacutainer® sst¿ tubes bd hemogard¿/gold had stoppers that fell off after processing.No serious injury, no medical interventions.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: 7097533
• MDR Text Key: 94639820
• Report Number: 1024879-2017-01029
• 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: 09/30/2017
• Device Catalogue Number: 367986
• Device Lot Number: 6266987
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2016
• 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