MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® BLOOD COLLECTION TUBES FOR MICROBIOLOGICAL STUDIES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	364960
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2021
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 when using the bd vacutainer¿ blood collection tubes for microbiological studies, the device experienced sterility issues (product not sterile), and erroneous results.The sterility event occurred 13 times.Erroneous results: not reported.The following information was provided by the initial reporter.The customer stated: the (b)(6) stem cell lab had a recent increase in positive sterilities using the yellow top sps tubes.During the investigation, the sps tubes were tested for sterility without any manipulation and were found to be positive for bacillus.The samples that are sent for sterility testing using these tubes are sterile critical products so the high number of false positives has caused many problems.The tube lot has been quarantined and we have not had any positive sterilities since.
Additional Manufacturer Narrative
H.6.Investigation: bd received 5 samples for investigation, however testing of samples is not the preferred method for this type of investigation.The sps product 364960 batch 0316301 was manufactured on november 25th 2020- nov 28th 2020 on line 5.A review of bioburden, sterility, and environmental routine test records from the time period of october 1st 2020- march 12th 2021 has been performed as those dates bracket the routine sterility dose audits performed before and after batch 0316301 was manufactured.The records reviewed were confirmed to be acceptable against limits.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 a sterility failure.Bd was not able to identify a root cause for the indicated failure mode.See h.10.
Event or Problem Description
It was reported when using the bd vacutainer® blood collection tubes for microbiological studies, the device experienced sterility issues (product not sterile), and erroneous results.The sterility event occurred 13 times.Erroneous results: not reported.The following information was provided by the initial reporter.The customer stated: the ucla stem cell lab had a recent increase in positive sterilities using the yellow top sps tubes.During the investigation, the sps tubes were tested for sterility without any manipulation and were found to be positive for bacillus.The samples that are sent for sterility testing using these tubes are sterile critical products so the high number of false positives has caused many problems.The tube lot has been quarantined and we have not had any positive sterilities since.

• Brand Name: BD VACUTAINER® BLOOD COLLECTION TUBES FOR MICROBIOLOGICAL STUDIES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12490212
• Report Number: 1917413-2021-00817
• Device Sequence Number: 19680991
• Product Code: JKA
• UDI-Device Identifier: 50382903649605
• UDI-Public: 50382903649605
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• 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): 11/23/2021

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: 11/30/2021
• Device Model Number: 364960
• Device Catalogue Number: 364960
• Device Lot Number: 0316301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2021
• Supplement Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 09/17/2021
• Supplement Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2020
• 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