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	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported during use the bd vacutainer® serum blood collection tubes experienced hemolysis (e.G.Blood sample).The following information was provided by the initial reporter: the customer stated while using the product the "sample had a hemolysis situation." the customer states "they are using their own blood collection needle to collect samples from the cubital vein.After collection, blood is inverted 5-8 times and transferred to centrifuge room, then placed in a symmetrical position.".
Event or Problem Description
It was reported during use the bd vacutainer® serum blood collection tubes experienced hemolysis (e.G.Blood sample).The following information was provided by the initial reporter: the customer stated while using the product the "sample had a hemolysis situation." the customer states "they are using their own blood collection needle to collect samples from the cubital vein.After collection, blood is inverted 5-8 times and transfered to centrifuge room, then placed in a symmetrical position.".
Additional Manufacturer Narrative
Investigation summary bd had not received samples, but 9 photos were provided for investigation.The photos were reviewed and the indicated failure mode for hemolysis with the incident lot was not observed.The customer provided 9 photos for the investigation.Two show serum pour off tubes.Hemolysis is visible in some of the pour off tubes, however, this complaint cannot be confirmed based on pour off tubes.Three photos show the needle sets used presumably for collection.No information on hemolysis can be seen from these photos.Four photos show bd serum red top tubes.No hemolysis is visible.All tubes look to be underfilled.Additionally, retention samples of the incident lot were selected from bd inventory for evaluation and upon completion, no issues relating to hemolysis were observed.No difficulties were encountered during blood collection and all tubes appeared to exhibit proper fill.Bd was unable to duplicate or confirm the customer¿s indicated failure, hemolysis, because the defects were not evident in the testing of the customer lot samples.Evaluations of both retain and control samples tested were acceptable.All tubes demonstrated clinically acceptable performance for all visual observations evaluated.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 was unable to confirm this complaint for hemolysis.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h.10.

• 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
• MDR Report Key: 10203121
• Report Number: 1024879-2020-00428
• Device Sequence Number: 2404964
• Product Code: JKA
• UDI-Device Identifier: 50382903666688
• UDI-Public: 50382903666688
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: BK050036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2021

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: 08/31/2020
• Device Model Number: 366668
• Device Catalogue Number: 366668
• Device Lot Number: 9122779
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 01/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other