MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® EDTA 2K; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367846

Device Problem Inaccurate Information (4051)

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

Event Date 08/01/2022

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® edta 2k the fill line position was incorrect.The following information was provided by the initial reporter.The customer stated: "printing of the fill line was found to be defective.".

Event Description

It was reported when using the bd vacutainer® edta 2k the fill line position was incorrect.The following information was provided by the initial reporter.The customer stated: "printing of the fill line was found to be defective.".

Manufacturer Narrative

H.6.Investigation summary mat: 367846; lot: 1195785.Bd did not receive samples or photos from the customer in support of this complaint.Therefore, 100 retention samples were visually inspected with no issues being identified.Bd was unable to confirm the customer¿s indicated failure mode because no samples or photos were returned.The device history records were reviewed with a quality notification for missing banding.All product affected was dispositions per manufacturing site procedures, no defective product was released.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.H3 other text : see h10.

Event Description

It was reported when using the bd vacutainer® edta 2k the fill line position was incorrect.The following information was provided by the initial reporter.The customer stated: "printing of the fill line was found to be defective.".

Manufacturer Narrative

The following fields have been updated with additional information: h.5 imdrf annex b grid : b01 - testing of actual/suspected device.H.6.Investigation summary: mat: 367846.Lot: 1195785.Bd received 1 photo were returned by the customer in support of this complaint.The evaluation of the photo shows a tube filled with blood, the tube is missing the printed see-through label.Additionally, 100 retention samples were visually inspected with no issues being identified.Bd was able to confirm the customer¿s indicated failure mode with the photo that was returned.The exact cause for the customer's failure mode could not be determined.The device history records were reviewed with a quality notification for missing banding.All product affected was dispositions per manufacturing site procedures, no defective product was released.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.H3 other text : see h.10.

• Brand Name: BD VACUTAINER® EDTA 2K
• 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: 15238102
• MDR Text Key: 305178818
• Report Number: 1917413-2022-00501
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K981013
• 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,Followup
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 367846
• Device Lot Number: 1195785
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2021
• 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