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

Catalog Number	367981
Medical Device Problem Codes	Short Fill (1575); Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/13/2019
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 that the bd vacutainer® sst¿ blood collection tube had foreign "speckles" in it, and underfilled during use due to having an inadequate vacuum.The "speckles" were later confirmed to be the clot activator additive spray coated onto the tube.This complaint was created to capture the 3rd of 6 related incidents.The following information was provided by the initial reporter: "it has been brought to our attention by a customer complaint, regarding bd vacutainers with serum separator.The vials have speckles on the inside of the vial and did not have enough suction to get the adequate amount of blood into the vial.These vacutainers have been exposed to temperature levels that exceed the manufactures controlled temperature compliance that is listed on the outside of the vial." additional information states: explained that the "speckles" in these tubes are the clot activator.In the edta tube, the additive is spray coated on the sides and the clot activator in serum tube is also spray coated on the sides of the walls.All of these "speckles" are normal.
Additional Manufacturer Narrative
Investigation summary: bd had not received samples or photos from the customer facility for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint.Therefore, a review of the device history record could not be conducted.
Event or Problem Description
It was reported that the bd vacutainer® sst¿ blood collection tube had foreign "speckles" in it, and underfilled during use due to having an inadequate vacuum.The "speckles" were later confirmed to be the clot activator additive spray coated onto the tube.This complaint was created to capture the 3rd of 6 related incidents.The following information was provided by the initial reporter: "it has been brought to our attention by a customer complaint, regarding bd vacutainers with serum separator.The vials have speckles on the inside of the vial and did not have enough suction to get the adequate amount of blood into the vial.These vacutainers have been exposed to temperature levels that exceed the manufactures controlled temperature compliance that is listed on the outside of the vial." additional information states: explained that the "speckles" in these tubes are the clot activator.In the edta tube, the additive is spray coated on the sides and the clot activator in serum tube is also spray coated on the sides of the walls.All of these "speckles" are normal.

• 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
• MDR Report Key: 9134656
• Report Number: 1024879-2019-01719
• Device Sequence Number: 1951581
• Product Code: JKA
• UDI-Device Identifier: 50382903679817
• UDI-Public: 50382903679817
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 367981
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 09/13/2019
• Supplement Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 09/30/2019
• Supplement Report FDA Received Date: 11/01/2019
• 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