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 Problems Pain (1994); Skin Inflammation/ Irritation (4545)

Event Date 03/06/2023

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone #: (b)(6).Investigation summary: no customer samples and no photos were received in support of this complaint from catalog 367841, lot number 2018841.The 100 retentions were visually inspected with the hemogard closure assembly correctly assembled and placed on the tubes.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.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.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that during use with bd vacutainer® k2 edta (k2e) 3.6mg blood collection tubes the tube underfilled.Patient was re-drawn and with 2nd puncture the site was red, swollen and painful.The following information was provided by the initial reporter, translated from chinese to english: on (b)(6) 2023, the patient was admitted to the hospital for schizophrenia.After admission, a routine examination was performed.When the medical staff used the vacuum blood collection tube to collect blood from the patient, they found that the negative pressure of the vacuum blood collection tube was insufficient, and the blood collection volume was insufficient, which could not meet the laboratory requirements.The staff immediately discarded the blood collection tube, replaced it with another new vacuum blood collection tube, replaced the blood collection site, and re-punctured the blood collection for the patient again, and the blood collection went smoothly.In this adverse event, the second puncture aggravated the anxiety of the patient, and the original puncture site was red, swollen and painful.

• 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 ; 8448235433
• MDR Report Key: 16790740
• MDR Text Key: 313825699
• Report Number: 1917413-2023-00320
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903678414
• UDI-Public: (01)50382903678414
• 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: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2023
• 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: 04/04/2023
• 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