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

Model Number	366668
Medical Device Problem Code	Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that prior to use with 100 bd vacutainer® serum blood collection tubes the additive appeared to be abnormal.The following information was provided by the initial reporter: the customer reported abnormality with the additive coating of the tubes in box they recently opened.
Additional Manufacturer Narrative
The following fields have been updated with additional information: d.10 device available for eval? yes.D.10 returned to manufacturer on: 1-may-2023.Investigation summary: bd received 83 samples and 1 photo for investigation.The photo was reviewed and the customer¿s indicated failure mode for additive abnormality was not observed.Additionally, the customer samples were evaluated by visual examination and the indicated failure mode for additive abnormality with the incident lot was 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 additive abnormality.Bd was not able to identify a root cause for the indicated failure mode.
Event or Problem Description
It was reported that prior to use with 100 bd vacutainer® serum blood collection tubes the additive appeared to be abnormal.The following information was provided by the initial reporter: the customer reported abnormality with the additive coating of the tubes in box they recently opened.

• Brand Name: BD VACUTAINER® SERUM BLOOD COLLECTION TUBES
• Common Device Name: 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 ; 8448235433
• MDR Report Key: 16781771
• Report Number: 1024879-2023-00244
• Device Sequence Number: 6849624
• Product Code: JKA
• UDI-Device Identifier: 50382903666688
• UDI-Public: (01)50382903666688
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: BK050036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2023

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
• Operator of Device: Other
• Device Expiration Date: 12/31/2023
• Device Model Number: 366668
• Device Catalogue Number: 366668
• Device Lot Number: 2244902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2023
• Supplement Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 06/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown