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

Catalog Number 364941

Device Problems Delivered as Unsterile Product (1421); Missing Information (4053)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/12/2023

Event Type  malfunction  

Event Description

It was reported that before usage of bd vacutainer® urine collection cup the customer reported sterility and no label/missing label information issues.The following was reported by the initial reporter: it was reported by the customer that they are having packaging issue with the box of urine collection cups they received (item 364941).The customer sent a picture indicating that the plastic bag containing the cups had been opened and that some of the cups were missing labels.

Manufacturer Narrative

H.6.Investigation summary: material #: 364941 lot/batch #: unknown bd had not received samples, but 1 photo was provided for investigation.The photo was reviewed and the indicated failure mode for open package and missing label information was not observed.The visual evaluation of the photo shows a bag of cups that is closed, all cup lids that can be seen in the bag do have a label on the opening of the cannula well.The photo does not show the customer¿s failure modes in addition, bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.This complaint is unable to be confirmed.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD VACUTAINER® URINE COLLECTION CUP
• Type of Device: SPECIMEN TRANSPORT AND STORAGE CONTAINER
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17925823
• MDR Text Key: 326373356
• Report Number: 1917413-2023-01010
• Device Sequence Number: 1
• Product Code: KDT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 364941
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1