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 11/25/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: bd did not receive samples or photographs from the customer in support of this complaint.Therefore, 20 retained samples were functionally draw-tested and the customer's indicated failure mode of underfill was not observed as all 20 tubes drew within specification.Bd was unable to confirm customers indicated failure mode based on the retained samples test results.No definitive root cause could be established for the reported defect.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.

Event Description

It was reported when using the bd vacutainer® 9nc 0.109m plus blood collection tube there was under-fill or low draw of a tube with blood.The following information was provided by the initial reporter.The customer stated: "during use, the tube was found to have a low draw issue.".

• 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: 13114553
• MDR Text Key: 286007567
• Report Number: 9617032-2021-01340
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903630955
• UDI-Public: 50382903630955
• 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: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2022
• Device Model Number: 363095
• Device Catalogue Number: 363095
• Device Lot Number: 1203612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2021
• 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