MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	367899
Medical Device Problem Codes	Device Markings/Labelling Problem (2911); Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported the bd vacutainer® k2 edta (k2e) 10.8mg blood collection tubes experienced label lift off/partial peel off.The following information was provided by the initial reporter.The customer stated: "as i stated on the phone, it may be a label issue and not a tube issue.We were trying to determine the root cause and wondering if there was any new type of coating on the bd tubes.So far the new label we used today seems promising, with only one label lifting off of 52 tubes.".
Additional Manufacturer Narrative
H6: investigation summary: bd had received 1 samples and 1 photos for investigation.The photos were reviewed and the indicated failure mode for label lift with the incident lot was not observed.The samples were reviewed and the indicated failure mode for label lift with the incident lot was not observed.Additionally, 100 retention samples from bd inventory were evaluated by visual examination and no issues were observed relating to label lift 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.
Event or Problem Description
It was reported the bd vacutainer® k2 edta (k2e) 10.8mg blood collection tubes experienced label lift off/partial peel off.The following information was provided by the initial reporter.The customer stated: "as i stated on the phone, it may be a label issue and not a tube issue.We were trying to determine the root cause and wondering if there was any new type of coating on the bd tubes.So far the new label we used today seems promising, with only one label lifting off of 52 tubes.".

• Brand Name: BD VACUTAINER K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 11446208
• Report Number: 1917413-2021-00167
• Device Sequence Number: 4048563
• Product Code: JKA
• UDI-Device Identifier: 50382903678995
• UDI-Public: 50382903678995
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: BK980011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 10/31/2021
• Device Model Number: 367899
• Device Catalogue Number: 367899
• Device Lot Number: 0133382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 03/14/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 03/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1