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

Catalog Number	367981
Medical Device Problem Code	Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.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 or Problem Description
It was reported when using the bd vacutainer® sst¿ blood collection tubes, the device experienced poor barrier separation of sample.The following information was provided by the initial reporter.The customer stated: it was reported that the serum or clot is not separating out very nicely.Customer tried taking multiple samples from different animals and compared them to a competitor tube as well.Item still failed to separate.
Event or Problem Description
It was reported when using the bd vacutainer® sst¿ blood collection tubes, the device experienced poor barrier separation of sample.The following information was provided by the initial reporter.The customer stated: it was reported that the serum or clot is not separating out very nicely.Customer tried taking multiple samples from different animals and compared them to a competitor tube as well.Item still failed to separate.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d4: medical device lot #: 1279764 d4: medical device expiration date: 2022-09-30 h4: device manufacture date: 2021-10-06 h6: investigation summary bd had not received samples, but 3 photos were provided for investigation.The photos were reviewed and the indicated failure mode for poor barrier separation 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.Bd's technical service provided guidance and educational materials.This product is intended for human use only.Bd does not have animal data for this product family.The veterinary use is considered an off-label use of this product.This complaint has been confirmed for the indicated failure mode poor barrier separation based on photos only.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h10.

• Brand Name: BD VACUTAINER® SST¿ 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: 13641718
• Report Number: 1024879-2022-00106
• Device Sequence Number: 13994039
• Product Code: JKA
• UDI-Device Identifier: 00382903679812
• UDI-Public: 00382903679812
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2022

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: 09/30/2022
• Device Catalogue Number: 367981
• Device Lot Number: 1279764
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2022
• Supplement Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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