MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBE; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	367855
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: 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) 5.4mg blood collection tube there was under-fill or low draw of a tube with blood.The following information was provided by the initial reporter.The customer stated: "the tubes have low draw volume.".
Event or Problem Description
It was reported when using the bd vacutainer® k2 edta (k2e) 5.4mg blood collection tube there was under-fill or low draw of a tube with blood.The following information was provided by the initial reporter.The customer stated: "the tubes have low draw volume.".
Additional Manufacturer Narrative
H6: investigation summary: no samples and no photos were returned by the customer in support of this complaint catalog 367855, lot number 1098451.Product expired 31aug2022.Bd was unable to confirm the customer¿s indicated failure mode based on the investigation completed.The device history records were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.

• Brand Name: BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBE
• 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: 15958771
• Report Number: 1917413-2022-00777
• Device Sequence Number: 5574213
• Product Code: JKA
• UDI-Device Identifier: 50382903678551
• UDI-Public: 50382903678551
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K971449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 12/13/2022

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 Model Number: 367855
• Device Catalogue Number: 367855
• Device Lot Number: 1098451
• 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: 11/16/2022
• Supplement Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 12/12/2022
• Supplement Report FDA Received Date: 12/28/2022
• 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