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

Catalog Number 367983

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2017

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the stopper pulled out of a bd vacutainer® plus plastic sst tube.Gold bd hemogard¿ closure during use.No injury or medical intervention.

Manufacturer Narrative

Investigation summary: bd received samples from the customer facility for investigation.Bd acknowledges that the customer's indicated failure mode for stopper pullout with the incident lot was observed.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Bd is aware of this product issue and further investigation has been initiated through a capa.The investigation is still on-going and improvements will be made as the potential causes of this issue are identified.Investigation conclusion: bd acknowledges the customer¿s indicated failure mode for stopper pullout with the incident lot.Further investigation has been initiated for this product issue.The investigation is still on-going and improvements will be made as the potential causes are identified.Root cause description: a capa has been initiated to document further investigation and root cause analysis relating to this product issue.The investigation is currently on-going and will be updated as the potential root cause(s) are identified.

• Brand Name: BD VACUTAINER® PLUS PLASTIC SST TUBE. GOLD BD HEMOGARD¿ CLOSURE
• 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: 7124490
• MDR Text Key: 95478259
• Report Number: 1024879-2017-01255
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679831
• UDI-Public: 50382903679831
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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,Followup
• Report Date: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: 367983
• Device Lot Number: 7135828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2017
• 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