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

Model Number	362725
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the bd vacutainer® est z (no additive) plus blood collection tube there was under-fill or low draw of a tube with blood.The following information was provided by the initial reporter.The customer stated: "we have been alerted by several departments of the hospital centre of a lack of vacuum for purge tubes (ref (b)(4) of batch 2056870.".
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 when using the bd vacutainer® est z (no additive) plus blood collection tube there was under-fill or low draw of a tube with blood.The following information was provided by the initial reporter.The customer stated: "we have been alerted by several departments of the hospital centre of a lack of vacuum for purge tubes (ref 362725) of batch 2056870.".
Additional Manufacturer Narrative
H.6.Investigation summary: bd had not received samples or photos for investigation.Therefore, 20 retention samples from bd inventory were evaluated by functional testing and no issues were observed relating to underfill 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.This complaint is unable to be confirmed for the indicated failure mode underfill.Bd was not able to identify a root cause for the indicated failure mode.
Event or Problem Description
It was reported when using the bd vacutainer® est z (no additive) plus blood collection tube there was under-fill or low draw of a tube with blood.The following information was provided by the initial reporter.The customer stated: "we have been alerted by several departments of the hospital centre of a lack of vacuum for purge tubes (ref 362725) of batch 2056870.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval: yes.D9: returned to manufacturer on: 2022-09-20.H.6.Investigation summary: bd received 11 samples from the customer in support of this complaint.The 11 customer samples along 20 retained samples from the bd inventory were functionally tested and the issue of underfill was not observed.Bd was unable to confirm customers indicated failure mode based on the returned and retained samples test results.The device history records were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.Information will be captured on trend reports and monitored.

• Brand Name: BD VACUTAINER® EST Z (NO ADDITIVE) PLUS BLOOD COLLECTION TUBE
• Common Device Name: SPECIMEN TRANSPORT AND STORAGE CONTAINER
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15351387
• Report Number: 9617032-2022-00824
• Device Sequence Number: 5863249
• Product Code: FMH
• UDI-Device Identifier: 50382903627252
• UDI-Public: 50382903627252
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/22/2022

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: 08/31/2023
• Device Model Number: 362725
• Device Catalogue Number: 362725
• Device Lot Number: 2056870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2022
• Supplement Date Received by Manufacturer: 09/09/2022; 09/22/2022
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 09/20/2022; 10/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown