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

Model Number 367955

Device Problem Device Ingredient or Reagent Problem (2910)

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

Event Date 12/02/2022

Event Type  malfunction  

Event Description

It was reported when using the bd vacutainer® sst¿ ii advance plus blood collection tubes has problems with dry gel tubes.The following information was provided by the initial reporter.The customer stated: "our technical platform in cahors victor hugo has also reported problems with dry gel tubes on the following lots: lots 2164897- 2145913- 2171047- 2125067.".

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 2164897, medical device expiration date: 2023-12-31, device manufacture date:2022-06-13.Medical device lot #: 2145913, medical device expiration date: 2023-11-30, device manufacture date: 2022-05-25.Medical device lot #: 2171047, medical device expiration date: 2023-12-31, device manufacture date: 2022-06-20.Medical device lot #: 2125067, medical device expiration date: 2023-11-30, device manufacture date: 2022-05-05.

Manufacturer Narrative

Lot/batch #: 2164897, 2171047.Bd had not received samples, but 2 photo was provided for investigation.The photo was reviewed and the indicated failure mode for red cell hang up was observed.A complaint history review was performed and revealed a confirmed complaint trend for some sample quality issues including red cell hang-up.Based on the confirmed complaint trend a capa (corrective and preventive action) was initiated.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 red cell hang up based on the trend identified and the photo provided.A corrective and preventive action was created to address the 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.Lot/batch #: 2145913, 2125067.Bd had not received samples, but 2 photos were provided for investigation.The photos were reviewed and the indicated failure mode for red cell hang up was observed.Additionally, retention samples of the incident lot were selected from bd inventory for evaluation and upon completion, the indicated failure mode for red cell hang up was not observed.There were no difficulties encountered during blood collection and all tubes appeared to exhibit proper fill.Bd was unable to duplicate the customer¿s indicated failure mode, red cell hang up, because the defect was not evident in the testing of the complaint lot samples.All visual observations of both retain and control samples tested demonstrated clinically acceptable performance.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 red cell hang up based on photos only.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.

Event Description

It was reported when using the bd vacutainer® sst¿ ii advance plus blood collection tubes has problems with dry gel tubes.The following information was provided by the initial reporter.The customer stated: "our technical platform in cahors victor hugo has also reported problems with dry gel tubes on the following lots: lots 2164897- 2145913- 2171047- 2125067.".

• 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: 16075297
• MDR Text Key: 308467808
• Report Number: 9617032-2022-01337
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2023
• Device Model Number: 367955
• Device Catalogue Number: 367955
• Device Lot Number: 2125067
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2022
• 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