MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® LITHIUM HEPARINN BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 367884

Device Problems Inability to Auto-Fill (1044); Short Fill (1575)

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

Event Date 09/26/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported when using the bd vacutainer® lithium heparinn blood collection tubes had low draw and tube push off issue.This event occurred 50 times.The following information was provided by the initial reporter.The customer stated: during using the tube, it was found that the tube had low draw and tube push off issue.

Event Description

It was reported when using the bd vacutainer® lithium heparinn blood collection tubes had low draw and tube push off issue.This event occurred 50 times.The following information was provided by the initial reporter.The customer stated: ¿during using the tube, it was found that the tube had low draw and tube push off issue.¿.

Manufacturer Narrative

H.6.Investigation summary: material #: 367884.Lot/batch #: 1350354.Bd had not received samples or photos for evaluation.Therefore, ten (10) retention samples from bd inventory were visually inspected and functional testing was perform.No issues were observed relating to underfill or tube push off.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 of underfill and tube push off.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h.10.

• Brand Name: BD VACUTAINER® LITHIUM HEPARINN 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: 15522278
• MDR Text Key: 301676890
• Report Number: 1917413-2022-00615
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903678841
• UDI-Public: 50382903678841
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K945952
• 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,Followup
• Report Date: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• 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: 367884
• Device Catalogue Number: 367884
• Device Lot Number: 1350354
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2021
• 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