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

Model Number	366668
Medical Device Problem Codes	Short Fill (1575); Defective Component (2292); Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 when using the bd vacutainer® serum blood collection tube there was under-fill or low draw of a tube with blood, discolored/abnormal additive form and defective component the following information was provided by the initial reporter.The customer stated: the " tubes have air bubbles in them thus resulting in additive abnormality and "negative pressure" which is resulting in draw volume.".
Additional Manufacturer Narrative
H.6.Investigation summary: catalog number: 366668.Batch number: 1298002.The device history record was reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.Bd sumter received 1 customer photo and 1 shelf pack (100 customer samples) for review and analysis.The photos confirm the reported issue of additive abnormality in the tubes.The photos are unable to confirm underfill and decapping/stopper creepout.Therefore, this complaint for additive abnormality is confirmed.29 customer samples were sent to franklin lakes for appropriate testing for 2nd stopper creepout/ decapping.The samples were subjected to a 1st and 2nd stopper pullout test with 0 of 5 samples resulting in 2nd stopper creepout/ decapping.Therefore, bd is unable to confirm decapping based on customer sample testing results.Based on a review of batch records and the investigation results, no root cause from the manufacturing process has been identified as a contributor to decapping/stopper creepout.20 customer samples were subjected to a draw test for low or no draw.All tubes were within specification.Tubes ranged in draw from 2.810(ml) ¿ 2.855(ml) with a specification range of 2.7(ml) ¿ 3.3(ml).The stated label draw of 3.0 ml draw based on a review of batch records and the investigation results, no root cause from the manufacturing process has been identified as a contributor to underfill.30 customer samples were subjected to a visual test for additive abnormality.12 of 30 customer samples failed the visual inspection test for additive abnormality.Therefore, bd is able to confirm the additive abnormality through visual inspection.Bd was able to confirm the customer¿s reported failure mode with the photos provided by the customer.The root cause of the additive abnormality is a clogged nozzle, normal processes include a visual inspection by a ta every 1 hour.Further processing of the tube occurred as a result of inadequate purging of the tube.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
Event or Problem Description
It was reported when using the bd vacutainer® serum blood collection tube there was under-fill or low draw of a tube with blood, discolored/abnormal additive form and defective component the following information was provided by the initial reporter.The customer stated: the " tubes have air bubbles in them thus resulting in additive abnormality and "negative pressure" which is resulting in draw volume.".

• 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 ; 8015296192
• MDR Report Key: 14959618
• Report Number: 1024879-2022-00344
• Device Sequence Number: 5586618
• Product Code: JKA
• UDI-Device Identifier: 50382903666688
• UDI-Public: 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): 08/08/2022

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: 02/28/2023
• Device Model Number: 366668
• Device Catalogue Number: 366668
• Device Lot Number: 1298002
• 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: 06/10/2022
• Supplement Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2021
• 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