MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® 9NC 0.109M PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 363095

Device Problem Short Fill (1575)

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

Event Date 06/16/2022

Event Type  malfunction  

Event Description

It was reported when using the bd vacutainer® 9nc 0.109m plus blood collection tubes the negative pressure was not enough for blood collection.The following information was provided by the initial reporter.The customer stated: "the nurse collected the patient's blood for testing.The process of collecting the yellow tube was smooth, and then the blue tube was collected, and the blood did not flow out until enough blood was collected.The nurse judged that the negative pressure of the blood collection tube was not enough, and immediately replaced the blue tube for the patient, and the collection went smoothly.".

Manufacturer Narrative

Investigation summary: "bd did not receive samples or photographs from the customer in support of this complaint.The expiry date of the lot number involved was (b)(6) 2022.Bd was unable to duplicate or confirm the customer¿s indicated failure mode because the tubes has expired, however retained tubes for a previous investigation were evaluated for the same defect and the issue of underfill was not observed.Bd was not able to identify a root cause for the indicated failure mode.".

• Brand Name: BD VACUTAINER® 9NC 0.109M PLUS BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16039690
• MDR Text Key: 308375996
• Report Number: 9617032-2022-01319
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K013971
• 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: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2022
• Device Model Number: 363095
• Device Catalogue Number: 363095
• Device Lot Number: 2040982
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2022
• 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