MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	367842
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 tubes are under filling with a bd vacutainer® k2 edta (k2e) 3.6mg blood collection tubes.The following information was provided by the initial reporter: it was reported that tubes not filling completely.Additional information received: the pink top tube did not fill up to the 2 ml mark (should be the same as the lavender).I did the same at wp but this time i used a calibrated pipette to get exactly 2 ml into the pink and the lavender was the shorter one.Funny thing is that i have some in the car which i filled up earlier in the week with glucola and those (pink and lav.) are at exactly the same level but slightly below the mark on the manufacturer label.
Additional Manufacturer Narrative
Investigation summary: bd had not received samples, but photos were provided by the customer facility for investigation.The photos were evaluated and the customer's indicated failure mode for underfill with the incident lot was not observed.However, 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.Bd has initiated further investigation relating to this issue through capa 260774 and potential causes have been identified.As a result, corrective actions have been established and are in the process of being implemented.
Event or Problem Description
It was reported that tubes are under filling with a bd vacutainer® k2 edta (k2e) 3.6mg blood collection tubes.The following information was provided by the initial reporter: it was reported that tubes not filling completely.Additional information received: the pink top tube did not fill up to the 2 ml mark (should be the same as the lavender).I did the same at wp but this time i used a calibrated pipette to get exactly 2 ml into the pink and the lavender was the shorter one.Funny thing is that i have some in the car which i filled up earlier in the week with glucola and those (pink and lav.) are at exactly the same level but slightly below the mark on the manufacturer label.

• Brand Name: BD VACUTAINER® K2 EDTA (K2E) 3.6MG 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
• MDR Report Key: 9415525
• Report Number: 1917413-2019-02460
• Device Sequence Number: 19457934
• Product Code: JKA
• UDI-Device Identifier: 50382903678421
• UDI-Public: 50382903678421
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K981013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2019

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 Model Number: 367842
• Device Catalogue Number: 367842
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 11/18/2019
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 12/12/2019
• 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