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 Missing Information (4053)

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

Event Date 11/04/2022

Event Type  malfunction  

Event Description

It was reported when using the bd vacutainer® sst¿ ii advance plus blood collection tubes had no label.The following information was provided by the initial reporter.The customer stated: ¿no label.There is a label on the main packaging.There are no labels on the tubes.That's why the institution destroyed the test tubes.Such a problem was detected in only 1 package of products.".

Manufacturer Narrative

Investigation summary: bd did receive 2 photographs from the customer in support of this complaint.An evaluation of the attached photographs shows evidence of missing label on the tube.Additionally, 100 retained samples from the bd inventory were visually checked and no missing labels were found.Bd was able to confirm the customer¿s indicated failure mode based on the photographs provided, however retained samples were satisfactory.Bd was not able to identify a root cause for the indicated failure mode.The device history records were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.

• 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: 15848334
• MDR Text Key: 307709378
• Report Number: 9617032-2022-01179
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679558
• UDI-Public: 50382903679558
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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
• Report Date: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• 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: 2145912
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2022
• 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