MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER C&S PRESERVATIVE URINE TUBE; TRANSPORT CULTURE MEDIUM

Catalog Number	364951
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that during use foreign matter "moisture" was discovered in tube with a bd vacutainer® c&s preservative urine tube.The following information was provided by the initial reporter: i noticed that the inside of the grey top had a bit of moisture which caused the powder inside to clump and not break down once filled with an actual urine specimen.I am not aware of any erroneous results because the tubes were pulled before we could use any.
Event or Problem Description
It was reported that during use foreign matter "moisture" was discovered in tube with a bd vacutainer® c&s preservative urine tube.The following information was provided by the initial reporter: i noticed that the inside of the grey top had a bit of moisture which caused the powder inside to clump and not break down once filled with an actual urine specimen.I am not aware of any erroneous results because the tubes were pulled before we could use any.
Additional Manufacturer Narrative
H.6.Investigation: upon evaluation of the customer returned samples and photos, the customer¿s product issue was observed during visual evaluation and inspection.The tubes appear to have additive that is a liquid consistency.This issue is known as a ¿melt back¿, this happens when the 300-batch unit tray that the tubes are in is not sitting directly on the shelf in the lypholization unit.They are then unable to freeze and be dried without contact to the shelf.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 C&S PRESERVATIVE URINE TUBE
• Common Device Name: TRANSPORT CULTURE MEDIUM
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 10512136
• Report Number: 1917413-2020-00797
• Device Sequence Number: 3123774
• Product Code: JSM
• UDI-Device Identifier: 50382903649513
• UDI-Public: 50382903649513
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K024240
• 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): 09/10/2020

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: 09/30/2021
• Device Catalogue Number: 364951
• Device Lot Number: 0072426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2020
• Initial Date Received by Manufacturer: 08/19/2020
• Supplement Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 09/10/2020
• 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