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 Problem Component Incompatible (1108)

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

Event Date 02/01/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: bd had not received samples or photos for investigation.Therefore, ten (10) retention samples from bd inventory were evaluated by functional testing and no issues were observed relating to tube sticking in holder as all samples met specifications.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 is unable to be confirmed for the indicated failure mode of tube sticking in holder.Bd was not able to identify a root cause for the indicated failure mode.

Event Description

It was reported when using the bd vacutainer® sst¿ ii advance plus blood collection tube the tube is tight in the holder.The following information was provided by the initial reporter.The customer stated: there is an "intermittently recurring problem of the tube not fitting into the holder correctly and/or tube not able to be removed smoothly without using excessive force.".

Event Description

It was reported when using the bd vacutainer® sst¿ ii advance plus blood collection tube the tube is tight in the holder.The following information was provided by the initial reporter.The customer stated: there is an "intermittently recurring problem of the tube not fitting into the holder correctly and/or tube not able to be removed smoothly without using excessive force.".

Manufacturer Narrative

The following fields were updated due to additional information: returned to manufacturer on: 2022-03-11.Investigation summary bd received four (4) samples for investigation.The samples were evaluated by functional testing and the indicated failure mode for tube getting stuck in holder with the incident lot was not observed.Additionally, ten (10) retention samples from bd inventory were evaluated by functional testing and no issues were observed relating to tube getting stuck in holder as all samples met specifications.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 is unable to be confirmed for the indicated failure mode of tube getting stuck in holder.Bd was not able to identify a root cause for the indicated failure mode.

• 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: 13607250
• MDR Text Key: 286437600
• Report Number: 9617032-2022-00143
• 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: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 367958
• Device Lot Number: 1245684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2021
• 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