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

Catalog Number 368175

Device Problem Expiration Date Error (2528)

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

Event Date 02/01/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported when using the bd (b)(6) serum blood collection tube there was incorrect label information.The following information was provided by the initial reporter.The customer stated: "the expiration date on the outer label of the shelf pack package does not correspond to the expiration date on the tube in the shelf pack itself.".

Manufacturer Narrative

H6: investigation summary: bd had not received samples, but one (1) photo was provided for investigation.The photo was reviewed and the indicated failure mode for incorrect label information was observed.The photo does show that the expiration date on the single tube pictured does not match the expiration date on the shelf pack label picture.As the shrink wrap on the shelf pack is opened and there is a tube missing from the shelf pack, it cannot be confirmed that the incorrect label information is due to bd¿s manufacturing process.It also cannot be confirmed with absolute certainty that the tube pictured was originally placed into this shelf pack during manufacturing as the product is not unopened.Additionally, thirty (30) retention samples from bd inventory were evaluated by visual examination and the issue of incorrect label information was not observed.All samples passed showing no evidence of an incorrect expiration date on the tube label.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.The corresponding shelf pack label and tube label information were reviewed, with no errors being found.There were no related quality notifications.This complaint has been confirmed for the indicated failure mode of incorrect label information based on the photo provided.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h10.

Event Description

It was reported when using the bd vacutainer® serum blood collection tube there was incorrect label information.The following information was provided by the initial reporter.The customer stated: "the expiration date on the outer label of the shelf pack package does not correspond to the expiration date on the tube in the shelf pack itself.".

• Brand Name: BD VACUTAINER® SERUM 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: 13506878
• MDR Text Key: 285818201
• Report Number: 1024879-2022-00082
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: NA
• 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: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 368175
• Device Lot Number: 1158438
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2021
• 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