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

Model Number	367878
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 when using the bd vacutainer® lithium heparinn (lh) blood collection tubes there was missing additive.The following information was provided by the initial reporter.The customer stated: "vacutainers we received had no additives.Four cases (400 vials) were received with no powdery white solution in them.The lab informed us the blood samples sent last week were all bad.That¿s when we noticed that all the vials are empty.".
Event or Problem Description
It was reported when using the bd vacutainer® lithium heparinn (lh) blood collection tubes there was missing additive.The following information was provided by the initial reporter.The customer stated: "vacutainers we received had no additives.Four cases (400 vials) were received with no powdery white solution in them.The lab informed us the blood samples sent last week were all bad.That¿s when we noticed that all the vials are empty.".
Additional Manufacturer Narrative
Investigation: bd had not received samples, but two (2) photos were provided for investigation.The photos were reviewed and the indicated failure mode for 'missing additive' with the incident lot was not observed.Additionally, one hundred (100) retention samples from bd inventory were evaluated by visual examination and no issues were observed relating to 'missing additive' 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 identify a root cause for the indicated failure mode.H3 other text : see h.10.

• Brand Name: BD VACUTAINER LITHIUM HEPARINN (LH) 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: 12081334
• Report Number: 1917413-2021-00551
• Device Sequence Number: 11674513
• Product Code: JKA
• UDI-Device Identifier: 50382903678780
• UDI-Public: 50382903678780
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K945952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2021

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: 04/30/2022
• Device Model Number: 367878
• Device Catalogue Number: 367878
• Device Lot Number: 0316374
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/03/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 06/28/2021
• Supplement Report FDA Received Date: 07/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1