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 04/06/2023

Event Type  malfunction  

Event Description

It was reported that during use with bd vacutainer® k2 edta (k2e) 3.6mg blood collection tubes the tube had a low draw.The patient was recollected.The following information was provided by the initial reporter, translated from chinese to english: on (b)(6) 2023, the patient was hospitalized for schizophrenia.After admission, a routine blood collection examination was performed.When the nurse used a vacuum blood collection tube to collect blood from the patient, he found that the negative pressure of the vacuum blood collection tube was insufficient, and the amount of blood collected could not meet the inspection requirements and could not be sent for inspection normally.The nurse immediately discarded the faulty vacuum blood collection tube and replaced it with a new vacuum blood collection tube to collect blood from the patient again.This adverse event prolongs the time of blood collection, and the site of the second puncture is red, swollen and painful.

Manufacturer Narrative

E.1.Initial reporter phone #: (b)(6) h.6.Investigation summary: bd had not received samples or photos for investigation.Therefore, 10 retention samples from bd inventory were evaluated by functional testing and no issues were observed relating to underfill as all samples met specifications.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure mode underfill.Bd was not able to identify a root cause for the indicated failure mode.

• 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: 16897228
• MDR Text Key: 315023129
• Report Number: 1917413-2023-00404
• 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: 05/05/2023

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: Health Professional
• 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
• Initial Date Manufacturer Received: 04/20/2023
• Initial Date FDA Received: 05/09/2023
• 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