MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD KIT URIN CUP PLC 16X100 10.0 UA YEL; URINE COLLECTION DEVICE

Catalog Number	364981
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/10/2019
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.
Event or Problem Description
It was reported that erroneous results occurred with a bd kit urin cup plc 16x100 10.0 ua yel.The following information was provided by the initial reporter: (2 of 2 complaints) customer did an evaluation for preservative ua tubes vs non preservative ua tube.Customer is confused about the method comparison.They believe the method comparison should have better correlation.They do not understand the method is a sim-quantitative method.Additional information provided by customer: the study on the proposed tubes on our existing equipment has been completed.The following was noticed on the study.Protein results are affected when using preservative containing tubes (higher values obtained), and the study failed for this analyte.Leukocyte results are affected when using the preservative containing tubes (inconsistency on the low positives), and the study failed for this analyte.Ph results are affected when using preservative containing tubes (slightly higher values obtained on %50 of the specimens), and the study failed.Clarity on the urine was also affected, and vrmc has validated the instrument to report clarity directly from analyzer.Although this one was not as significant it still didn¿t pass the criteria.
Additional Manufacturer Narrative
H.6.Investigation summary: bd had not received samples or photos from the customer facility for evaluation.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Clsi guidelines indicate a sample size of at least 20 for this process.The customer has indicated a sample size of only 4 for this method comparison.In addition, it may be helpful to set a threshold preservative level in this situation because of the nature of these sample types that are being compared and potential background issues that may be encountered.
Event or Problem Description
It was reported that erroneous results occurred with a bd kit urin cup plc 16x100 10.0 ua yel.The following information was provided by the initial reporter: (2 of 2 complaints) customer did an evaluation for preservative ua tubes vs non preservative ua tube.Customer is confused about the method comparison.They believe the method comparison should have better correlation.They do not understand the method is a sim-quantitative method.Additional information provided by customer: the study on the proposed tubes on our existing equipment has been completed.The following was noticed on the study.Protein results are affected when using preservative containing tubes (higher values obtained), and the study failed for this analyte.Leukocyte results are affected when using the preservative containing tubes (inconsistency on the low positives), and the study failed for this analyte.Ph results are affected when using preservative containing tubes (slightly higher values obtained on %50 of the specimens), and the study failed.Clarity on the urine was also affected, and vrmc has validated the instrument to report clarity directly from analyzer.Although this one was not as significant it still didn't pass the criteria.

• Brand Name: BD KIT URIN CUP PLC 16X100 10.0 UA YEL
• Common Device Name: URINE COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 9527947
• Report Number: 1917413-2019-02577
• Device Sequence Number: 2883908
• Product Code: JTW
• UDI-Device Identifier: 00382903649815
• UDI-Public: 00382903649815
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 364981
• Device Lot Number: 9058550
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 12/27/2019
• Supplement Report FDA Received Date: 03/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other