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

Catalog Number	364979
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/18/2020
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.(b)(4).
Event or Problem Description
It was reported that during use with a bd vacutainer® urinalysis urine tube there was loose closure and blood leakage occurred, also cracked tubes.Patient impact was not reported.The following information was provided by the initial reporter: it was reported that the tubes leaked because the top has come off or partially off and in some cases the tube has cracked.
Event or Problem Description
It was reported that during use with a bd vacutainer® urinalysis urine tube there was loose closure and blood leakage occurred, also cracked tubes.Patient impact was not reported.The following information was provided by the initial reporter: it was reported that the tubes leaked because the top has come off or partially off and in some cases the tube has cracked.
Additional Manufacturer Narrative
H.6.Investigation: bd had not received samples or photos from the customer for evaluation.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 non-conformances during manufacturing of the product.

• 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
• MDR Report Key: 10673089
• Report Number: 1917413-2020-00935
• Device Sequence Number: 3385569
• Product Code: KDT
• UDI-Device Identifier: 50382903649797
• UDI-Public: 50382903649797
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (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): 11/02/2020

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: 02/28/2022
• Device Catalogue Number: 364979
• Device Lot Number: 0072442
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/23/2020
• Supplement Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 10/13/2020
• Supplement Report FDA Received Date: 11/02/2020
• 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