MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® URINALYSIS URINE TUBE; SPECIMEN TRANSPORT AND STORAGE CONTAINER

Model Number	364979
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported when using the bd vacutainer® urinalysis urine tube there was tube extenders with molding defects that can be used.The following information was provided by the initial reporter.The customer stated: "the tops are smaller causing the analyzer to drop the samples.".
Additional Manufacturer Narrative
The following fields have been updated with additional/corrected information: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: d.4.Medical device lot #: 1288661.D.4.Medical device expiration date: 2023-10-31.H.4.Device manufacture date: 2021-10-15.D.4.Medical device lot #: 1350285.D.4.Medical device expiration date: 2023-12-31.H.4.Device manufacture date: 2021-12-16.
Event or Problem Description
It was reported when using the bd vacutainer® urinalysis urine tube there was tube extenders with molding defects that can be used.The following information was provided by the initial reporter.The customer stated: "the tops are smaller causing the analyzer to drop the samples.".
Event or Problem Description
It was reported when using the bd vacutainer® urinalysis urine tube there was tube extenders with molding defects that can be used.The following information was provided by the initial reporter.The customer stated: "the tops are smaller causing the analyzer to drop the samples.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 17-mar-2022.H.6.Investigation: bd received eleven (11) samples from lot #1288661 and one (1) from lot #1350285 for investigation.The samples were evaluated by visual examination and the indicated failure mode for stopper size causing instrument issues with the incident lots were not observed, as no issues with the stoppers were identified.The stoppers were the correct size and material per the product specification.Additionally, one hundred (100) retention samples from each lot (1288661 and 1350285) from bd inventory were evaluated by visual examination and no issues were observed relating to stopper size/issues as all samples met specifications.Based on a review of the device history record for the incident lots, all product specifications and requirements for lot release were met.There were no related quality notifications.This complaint is unable to be confirmed for the indicated failure mode of stopper size causing instrument issues based on the returned and retention samples.Bd was not able to identify a root cause for the indicated failure mode.

• Brand Name: BD VACUTAINER® URINALYSIS URINE TUBE
• Common Device Name: SPECIMEN TRANSPORT AND STORAGE CONTAINER
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13698972
• Report Number: 1917413-2022-00114
• Device Sequence Number: 17476085
• Product Code: KDT
• UDI-Device Identifier: 50382903649797
• UDI-Public: 50382903649797
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K790366
• 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,Followup
• Report Date (Section B): 03/23/2022

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 Model Number: 364979
• Device Catalogue Number: 364979
• Device Lot Number: SEE H.10
• 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: 02/23/2022
• Supplement Date Received by Manufacturer: 03/11/2022; 03/23/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 03/15/2022; 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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