MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER EST Z (NO ADDITIVE) PLUS BLOOD COLLECTION TUBES; SPECIMEN TRANSPORT AND STORAGE CONTAINER

Model Number	362725
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that while using bd vacutainer® est z (no additive) plus blood collection tubes 42 tubes have cracked while freezing.There was no report of patient impact.The following information was provided by the initial reporter: tubes crack when freezing.-70 degrees c.Old protocol that has been working for years with our tubes.Until now 42 tubes has cracked and leaked the past 3 months.Same protocol and same equipment(freezers etc.) is used as before.
Event or Problem Description
It was reported that while using bd vacutainer® est z (no additive) plus blood collection tubes 42 tubes have cracked while freezing.There was no report of patient impact.The following information was provided by the initial reporter: tubes crack when freezing.-70 degrees c.Old protocol that has been working for years with our tubes.Until now 42 tubes has cracked and leaked the past 3 months.Same protocol and same equipment(freezers etc.) is used as before.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 12/16/2020.H.6.Investigation: bd received 380 samples for investigation.The samples were evaluated by visual examination and the indicated failure mode for tube breakage with the incident lot was not observed as all product specifications were met.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.

• Brand Name: BD VACUTAINER EST Z (NO ADDITIVE) PLUS BLOOD COLLECTION TUBES
• Common Device Name: SPECIMEN TRANSPORT AND STORAGE CONTAINER
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• MDR Report Key: 10951079
• Report Number: 9617032-2020-01001
• Device Sequence Number: 2419605
• Product Code: FMH
• UDI-Device Identifier: 50382903627252
• UDI-Public: 50382903627252
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (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): 01/27/2021

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: 03/31/2021
• Device Model Number: 362725
• Device Catalogue Number: 362725
• Device Lot Number: 9259616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 12/05/2020
• Supplement Report FDA Received Date: 01/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1