MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367988

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 01/19/2022

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Initial reporter state: address unavailable.Bd corporate state (b)(6) was used as its place holder.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported when using the bd vacutainer® sst¿ blood collection tubes, the user used the tube after the recommended expiration date.This event occurred 5 times.The following information was provided by the initial reporter.The customer stated: it was reported that tubes were used past expiration date.I have a customer on the line and she is wanting some sort of statement from bd about using our products beyond expiration date.They are using item 367988, she wants something that states that the tests they have run will not be affected due to the expiration date.Or something that states that there is an extension to the expiration date.The expiration date was 12/2021 and she has run about 5 or so tests and doesn't want to discard them and run them over.She wasn't sure when the incident date was exactly.She didn't have the lot number at the time of the call.

Manufacturer Narrative

Medical device expiration date: unknown.Initial reporter state: address unavailable.Bd corporate state (b)(6) was used as its place holder.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported when using the bd vacutainer® sst¿ blood collection tubes, the user used the tube after the recommended expiration date.This event occurred 5 times.The following information was provided by the initial reporter.The customer stated: it was reported that tubes were used past expiration date.I have a customer on the line and she is wanting some sort of statement from bd about using our products beyond expiration date.They are using item 367988, she wants something that states that the tests they have run will not be affected due to the expiration date.Or something that states that there is an extension to the expiration date.The expiration date was 12/2021 and she has run about 5 or so tests and doesn't want to discard them and run them over.She wasn't sure when the incident date was exactly.She didn't have the lot number at the time of the call.

• Brand Name: BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13428769
• MDR Text Key: 286270229
• Report Number: 1024879-2022-00054
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903679881
• UDI-Public: 00382903679881
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK050036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 367988
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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