MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 367861

Device Problem Material Protrusion/Extrusion (2979)

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

Event Date 03/30/2021

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 the bd vacutainer® k2 edta (k2e) 7.2mg blood collection tubes experienced molding defect sharp protrusions.The following information was provided by the initial reporter.The customer stated: "it was reported that there is excess plastic hanging off the side of the tube.This has caused two instrument errors where is crashed the probe.Have been faulty with excess plastic hanging off the side of the tube.So far per the lab they have pulled 4,000 tubes that were faulty.Manufacturer flaws in the tubes, two instrument errors in the last week and a half where it crashed our probe.".

Event Description

It was reported the bd vacutainer® k2 edta (k2e) 7.2mg blood collection tubes experienced molding defect sharp protrusions.The following information was provided by the initial reporter.The customer stated: "it was reported that there is excess plastic hanging off the side of the tube.This has caused two instrument errors where is crashed the probe.Have been faulty with excess plastic hanging off the side of the tube.So far per the lab they have pulled 4,000 tubes that were faulty.Manufacturer flaws in the tubes, two instrument errors in the last week and a half where it crashed our probe.".

Manufacturer Narrative

H.6.Investigation: bd received 500 samples and 5 photos for investigation.The photos were reviewed and the indicated failure mode for molding defect with the incident lot was not observed.Additionally, the customer samples along with retention samples from bd inventory, were evaluated by visual examination and no issues were observed relating to molding defect 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.Bd was not able to identifiy a root cause for the indicated failure mode.See h.10.

• Brand Name: BD VACUTAINER K2 EDTA (K2E) 7.2MG 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
• MDR Report Key: 11725350
• MDR Text Key: 248840974
• Report Number: 1917413-2021-00323
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903678612
• UDI-Public: 50382903678612
• Combination Product (y/n): N
• PMA/PMN Number: BK050036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• 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: 367861
• Device Catalogue Number: 367861
• Device Lot Number: 0345777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Date Manufacturer Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1