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

Catalog Number 367958

Device Problems Separation Failure (2547); Premature Separation (4045)

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

Event Date 11/08/2022

Event Type  malfunction  

Event Description

It was reported when using the bd vacutainer® sst¿ ii advance plus blood collection tube there was stopper pull out of the tube within a holder.This event occurred 6 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." 17-nov-2022 received additional information from the complainant.Nisaabd can you please provide name of the track and decapper so we can advise manufacturing? - it¿s the glp (good lab practice) track system that is now owned by abbott under aas (abbott automation solutions) website if you want to do some research: https://www.Corelaboratory.Abbott/int/en/offerings/brands/glp-systems the module is just called a decapper module (dm) ¿ i may be able to get some dm technical specifications from the abbott engineers but am unsure of ip restrictions and they may say no.

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #:2095141.Medical device expiration date: 2023-10-31.Device manufacture date: 2022-04-05.Medical device lot #: 2097412.Medical device expiration date: 2023-09-30.Device manufacture date:2022-04-07.Medical device lot #: 2052791.Medical device expiration date: 2023-08-31.Device manufacture date:2022-02-21.Medical device lot #: 2116003.Medical device expiration date: 2023-10-31.Device manufacture date: 2022-04-26.Medical device lot #: 2067694.Medical device expiration date: 2023-09-30.Device manufacture date: 2022-03-08.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

The following fields were updated due to corrected information: annex a code: a150301.B.5 describe event or problem: 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 6 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 6 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.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint has been confirmed for the indicated failure mode closure separation.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.

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 6 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.".

• Brand Name: BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE
• 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: 15931945
• MDR Text Key: 306192555
• Report Number: 9617032-2022-01241
• 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,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: SEE H.10
• 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