MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367958

Device Problem Separation Failure (2547)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/03/2022

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported when using the bd vacutainer® sst¿ ii advance plus blood collection tube the rubber stopper remained in tube (stopper/shield separation).This event occurred 2 times.The following information was provided by the initial reporter.The customer stated: there have been "an increasing number of tubes failing to decap correctly on the decapping instrument.The outer shield is removed while the rubber stopper remains in the tube.The have been several occurrences of such failures resulting in instrument errors and sampling probe crashes.".

Event Description

It was reported when using the bd vacutainer® sst¿ ii advance plus blood collection tube the rubber stopper remained in tube (stopper/shield separation).This event occurred 2 times.The following information was provided by the initial reporter.The customer stated: there have been "an increasing number of tubes failing to decap correctly on the decapping instrument.The outer shield is removed while the rubber stopper remains in the tube.The have been several occurrences of such failures resulting in instrument errors and sampling probe crashes.".

Manufacturer Narrative

Bd had not received samples, but four (4) photos were provided for investigation.The photos were reviewed and the indicated failure mode for closure separation was observed.Additionally, twenty four (24) bd inventory retention samples from each lot number provided were evaluated by functional testing and the issue of closure separation was not observed.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h.10.

• Brand Name: BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15935224
• MDR Text Key: 307929132
• Report Number: 9617032-2022-01250
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: BK050036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 367958
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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