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

Model Number 367957

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 11/30/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: "bd had not received samples, but one (1) photo was provided for investigation.Evaluation of the photograph shows evidence of dark red foreign matter on the top of the gel.Additionally, one hundred (100) retention samples from bd inventory were evaluated by visual examination and the issue of foreign matter 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.".

Event Description

It was reported when using the bd vacutainer® sst¿ ii advance plus blood collection tubes had abnormal additives, and foreign matter inside the tube.The following information was provided by the initial reporter.The customer stated: "when using the 367957 process, found that the additives of the product 367957 were abnormal, and impurities were found inside.".

Event Description

It was reported when using the bd vacutainer® sst¿ ii advance plus blood collection tubes had abnormal additives, and foreign matter inside the tube.The following information was provided by the initial reporter.The customer stated: "when using the 367957 process, found that the additives of the product 367957 were abnormal, and impurities were found inside.".

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for evaluation: yes.D9: returned to manufacturer on: 2022-12-03.H.6.Investigation summary: bd received one (1) sample and one (1) photo was provided for investigation.Evaluation of the photograph shows evidence of dark red foreign matter on the top of the gel.Evaluation of the sample indicated a small part of the stopper material inside the tube.Additionally, one hundred (100) retention samples from bd inventory were evaluated by visual examination and the issue of foreign matter 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.Bd was not able to identify a root cause for the indicated failure mode.

• 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: 16055266
• MDR Text Key: 308448670
• Report Number: 9617032-2022-01329
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 01/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2023
• Device Model Number: 367957
• Device Catalogue Number: 367957
• Device Lot Number: 1336524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2022
• Initial Date FDA Received: 12/27/2022
• Supplement Dates Manufacturer Received: 01/21/2023
• Supplement Dates FDA Received: 01/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2021
• 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