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

Catalog Number 367956

Device Problems Complete Blockage (1094); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 06/24/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone number: (b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that 500 bd vacutainer® sst¿ ii advance plus blood collection tubes had a blocked instrumentation probe.The following information was provided by the initial reporter: "issue with the gel in sst tube with probe blockage".

Event Description

It was reported that 500 bd vacutainer® sst¿ ii advance plus blood collection tubes had a blocked instrumentation probe and erroneous results.The following information was provided by the initial reporter: "issue with the gel in sst tube with probe blockage".

Manufacturer Narrative

The following fields have been updated with additional information: b.3 describe event or problem: it was reported that 500 bd vacutainer® sst¿ ii advance plus blood collection tubes had a blocked instrumentation probe and erroneous results.The following information was provided by the initial reporter: "issue with the gel in sst tube with probe blockage" h.4 imdrf annex a grid.A0908 - incorrect, inadequate or imprecise result or readings.

Manufacturer Narrative

H.6.Investigation summary: material #: 367956; lot/batch #: 1179691.Bd had not received samples or photos for evaluation.Therefore, retention samples of the incident lot were selected from bd inventory for evaluation and upon completion, no issues relating to oil gel globules and erroneous results were observed.There were no difficulties encountered during blood collection and all tubes appeared to exhibit proper fill.Bd was unable to confirm the customer¿s indicated failure mode (erroneous results/oil gel globules) because the defect was not evident in the testing of the complaint lot samples.Replicates of both retain and control samples were acceptable in terms of both precision and accuracy.All visual observations of both retain and control samples tested demonstrated clinically acceptable performance.All tubes performed as expected.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 oil gel globules and erroneous results.Bd was not able to identify a root cause for the indicated failure mode.Factors that may contribute to oil gel globules and erroneous results were evaluated through a clinical study to verify the design of the device met it¿s intended use.The result of the study showed that the device performed as expected and we were unable to determine any external contributor to this reported issue.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 that 500 bd vacutainer® sst¿ ii advance plus blood collection tubes had a blocked instrumentation probe and erroneous results.The following information was provided by the initial reporter: "issue with the gel in sst tube with probe blockage.".

• 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: 15067576
• MDR Text Key: 297987688
• Report Number: 9617032-2022-00669
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 367956
• Device Lot Number: 1179691
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2021
• 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