MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® URINALYSIS CONCIAL URINE TUBE NO ADDITIVE; SPECIMEN TRANSPORT AND STORAGE CONTAINER

Catalog Number 364980

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 01/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Investigation summary: no customer samples were received to be evaluated.3 photos were received.The 3 customer photos were inspected with no issues being identified.The device history records were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.Investigation conclusion: upon evaluation of the customer returned photos, the customer¿s product issue was not observed during visual inspection of the tube.This product does not contain additive per specification, no condensation was seen in the tube.The device history records were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.Root cause description: based on the investigation, no product issue was identified as the product was found to be in conformance and meet release specifications.Rationale: bd was unable to confirm the customer¿s indicated failure mode with the photos provided.Bd life sciences ¿ preanalytical systems received no samples and 3 photos from the customer facility for investigation.Based on the visual inspection/evaluation of the samples, bd pas did not observe ¿fm¿ on the product.The device history records were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.

Event Description

It was reported that two of the bd vacutainer® urinalysis concial urine tubes no additive experienced foreign matter contamination.

• Brand Name: BD VACUTAINER® URINALYSIS CONCIAL URINE TUBE NO ADDITIVE
• Type of Device: SPECIMEN TRANSPORT AND STORAGE CONTAINER
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 8336831
• MDR Text Key: 136855686
• Report Number: 1917413-2019-00233
• Device Sequence Number: 1
• Product Code: NNK
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/25/2019

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
• Device Operator: Other
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 364980
• Device Lot Number: 8187644
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2019
• Initial Date FDA Received: 02/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other