MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	367844
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/25/2022
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® k2 edta (k2e) 7.2mg blood collection tubes, the device experienced underfill or low draw of a tube with blood.This event occurred 10 times.The following information was provided by the initial reporter.The customer stated: at the moment of sample draw the tubes fill under the limit allowed, which it's required to assure accurate results for diagnostic support.
Additional Manufacturer Narrative
H.6.Investigation: no customer samples and 1 photo were received.The photo was visually evaluated showing the amount of specimen drawn into the tubes is below the etched fill line on the tube.As no customer samples were received at the manufacturing site, the investigation was limited.Therefore, 10 production lot in-house retention samples were inspected with 0 visible defects.Additionally, functional testing was performed on the retention samples and the customer's indicated failure mode of underfill was not observed as all tubes were within specification limits.Bd was able to confirm the customer¿s indicated failure mode with the photo provided; however, no samples were returned to be tested and the complaint could not be duplicated in the retention testing.The exact cause for the underfilling of the tube could not be determined.The quantity of blood drawn into evaluated tubes varies with altitude, ambient temperature, barometric pressure, tube age, venous pressure, and filling technique.The device history records were reviewed on the identified lot with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.
Event or Problem Description
It was reported when using the bd vacutainer® k2 edta (k2e) 7.2mg blood collection tubes, the device experienced underfill or low draw of a tube with blood.This event occurred 10 times.The following information was provided by the initial reporter.The customer stated: at the moment of sample draw the tubes fill under the limit allowed, which it's required to assure accurate results for diagnostic support.

• Brand Name: BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14389302
• Report Number: 1917413-2022-00258
• Device Sequence Number: 15084837
• Product Code: JKA
• UDI-Device Identifier: 00382903678440
• UDI-Public: 00382903678440
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 05/25/2022

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: 08/31/2022
• Device Catalogue Number: 367844
• Device Lot Number: 1098448
• 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: 05/05/2022
• Supplement Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 05/13/2022
• Supplement Report FDA Received Date: 05/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2021
• 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