MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) KIT URIN CUP 16X100 8.0 CONI UAP RD/YEL; URINE COLLECTION DEVICE

Catalog Number	364946
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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 underfill occurred with kit urine cup 16 x 100 8.0 coni uap rd/yel.The following information was provided by the initial reporter, "the tubes with the urine kit's conservator drains below the minimum line.Information received by email on 05/03/2019: it was reported at least 10 tubes without vacuum.They did not had any lot number changes (all affected products is from the same lot number).The tubes is stocked in ambient temperature (about 8ºc and 22ºc).The customer follow the fabricator instructions to perform the draining.'' 4200 occurrences were reported.
Event or Problem Description
It was reported that underfill occurred with kit urin cup 16x100 8.0 coni uap rd/yel.The following information was provided by the initial reporter, "the tubes with the urine kit's conservator drains below the minimum line.Information received by email on 5/3/2019: it was reported at least 10 tubes without vacuum.They did not had any lot number changes (all affected products is from the same lot number).The tubes is stocked in ambient temperatura (about 8ºc and 22ºc).The customer follow the fabricator instructions to perform the draining" 4200 occurrences were reported.
Additional Manufacturer Narrative
Investigation: investigation summary: bd received samples and photos from the customer facility for investigation.The photos were evaluated and the customer's indicated failure mode for underfilling with the incident lot was observed.The samples were draw tested and the samples drew within the required specifications.Additionally, retention samples were selected from bd inventory for testing and upon completion, the issue relating to underfill was not observed.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.Investigation conclusion: based on evaluation of the customer photos, the customer¿s indicated failure mode for underfilling with the incident lot was observed.Additionally, testing of the return and retain samples was conducted and underfill was not observed.Root cause description: based on the investigation, a root cause could not be determined.Rationale: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that underfill occurred with kit urin cup 16x100 8.0 coni uap rd/yel.The following information was provided by the initial reporter, "the tubes with the urine kit's conservator drains below the minimum line.Information received by email on 5/3/2019: it was reported at least 10 tubes without vacuum.They did not had any lot number changes (all affected products is from the same lot number).The tubes is stocked in ambient temperature (about 8ºc and 22ºc).The customer follow the fabricator instructions to perform the draining." 4200 occurrences were reported.
Additional Manufacturer Narrative
Investigation: investigation summary: bd had not received samples, but photos were provided by the customer facility for investigation.The photos were evaluated and the customer's indicated failure mode for underfilling with the incident lot was observed.Additionally, retention samples were selected from bd inventory for testing and upon completion, the issue relating to underfill was not observed.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.Investigation conclusion: based on evaluation of the customer photos, the customer¿s indicated failure mode for underfilling with the incident lot was observed.Additionally, testing of the retain samples was conducted and underfill was not observed.Root cause description: based on the investigation, a root cause could not be determined.Rationale: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: KIT URIN CUP 16X100 8.0 CONI UAP RD/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: 8608105
• Report Number: 1917413-2019-01462
• Device Sequence Number: 2472550
• Product Code: KDT
• UDI-Device Identifier: 50382903649469
• UDI-Public: 50382903649469
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,Followup
• Report Date (Section B): 06/19/2019

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: 09/30/2019
• Device Catalogue Number: 364946
• Device Lot Number: 8059545
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 04/23/2019; 04/23/2019
• Initial Report FDA Received Date: 05/14/2019
• Supplement Report FDA Received Date: 06/05/2019; 06/19/2019
• 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