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

Catalog Number 367862

Device Problem Short Fill (1575)

Patient Problem Discomfort (2330)

Event Date 07/03/2023

Event Type  malfunction  

Event Description

It was reported that during use with an unspecified amount of bd vacutainer® k2 edta (k2e) plus blood collection tubes the tubes were underfilled.Patient had to be re-stuck, no further patient impact was reported.The following information was provided by the initial reporter, translated from french to english: difficulty in carrying out the treatment obligation to prick the patient several times dissatisfaction on the part of the patient with having to prick the patient several times and on the part of the laboratory because the tubes are not full enough or are uncontrollable in their machine.

Manufacturer Narrative

H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

Investigation summary: material # 367862.Batch # 2347075.No samples and no photos were received in support of this complaint from catalog 367862, lot number 2347075.No customer samples and no photos were received; therefore, the investigation was limited.To ensure that tubes draw to an acceptable volume a number of factors should be considered: evacuated tubes are designed to draw the volume indicated.Filling is complete when vacuum no longer continues to draw.When using a winged blood collection set for venipuncture a discard tube should be drawn first to ensure the blood collection set tubing¿s ¿dead space¿ is filled with blood.The quantity of blood drawn varies with altitude, ambient temperature, barometric pressure, age of the tube, venous pressure and filling technique.Tubes with smaller draw volumes (partial draw tubes denoted by translucent closures) may fill more slowly, due to the lower vacuum, than tubes of the same size with larger draw volumes.(b)(4) retentions tubes were visually inspected with the hemogard closure assembly correctly assembled and placed on the tubes.A draw test was performed at the manufacturing site on 10-production lot in-house retention tubes.All tubes were within specification limits with no issues identified.Bd was unable to confirm the customer¿s indicated failure mode with the investigation completed.The device history records were reviewed with no issues being identified.

Event Description

It was reported that during use with an unspecified amount of bd vacutainer® k2 edta (k2e) plus blood collection tubes the tubes were underfilled.Patient had to be re-stuck, no further patient impact was reported.The following information was provided by the initial reporter, translated from french to english: difficulty in carrying out the treatment obligation to prick the patient several times dissatisfaction on the part of the patient with having to prick the patient several times and on the part of the laboratory because the tubes are not full enough or are uncontrollable in their machine.

• Brand Name: BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES
• Type of Device: 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17476635
• MDR Text Key: 321526128
• Report Number: 1917413-2023-00742
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903678629
• UDI-Public: (01)50382903678629
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: BK050036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/19/2023

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
• Device Operator: Other
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 367862
• Device Lot Number: 2347075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/24/2023
• Initial Date FDA Received: 08/07/2023
• Supplement Dates Manufacturer Received: 10/19/2023
• Supplement Dates FDA Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1