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 367841

Device Problem Short Fill (1575)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/23/2022

Event Type  malfunction  

Event Description

It was reported when using the bd vacutainer® k2 edta (k2e) 3.6mg blood collection tubes had insufficient suction during use.The following information was provided by the initial reporter.The customer stated: "during the blood drawing process, the nurse found that after sucking out about 1ml of blood with the negative pressure suction tube of batch number 2018841, the negative pressure in the tube was insufficient to continue sucking out blood, and this happened in all boxes.".

Manufacturer Narrative

Investigation summary: "no customer samples and no photos were received in support of this complaint from catalog 367841, lot number 2018841.Therefore, 100 retentions were visually inspected with the hemogard closure assembly correctly assembled and placed on the tubes.There were no cocked stoppers identified that would cause the hemogard closure assembly to not be applied correctly.The quantity of blood drawn into evaluated tubes varies with altitude, ambient temperature, barometric pressure, tube age, venous pressure, and filling technique.10 production lot in-house retention tubes were inspected with 0 visible defects.A draw test was performed at the manufacturing site on the 10-production lot in-house retention tubes.All tubes were within specification limits.Bd was unable to confirm the customer¿s indicated failure modes of underfill based on the investigation completed.The defect was not observed in the retention sample testing.".

• Brand Name: BD VACUTAINER® K2 EDTA (K2E) 3.6MG 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16051895
• MDR Text Key: 306840580
• Report Number: 1917413-2022-00809
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: BK050036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2023
• Device Model Number: 367841
• Device Catalogue Number: 367841
• Device Lot Number: 2018841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2022
• 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