MAUDE Adverse Event Report: BECTON DICKINSON APTACA URINE CUP 60 ML; TRANSPORT CULTURE MEDIUM

Catalog Number 364931

Device Problem Break (1069)

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

Event Date 12/21/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that 75000 bd aptaca urine cup 60 ml had the transfer straws dislodge.The following information was provided by the initial reporter, translated from french to english: "very frequently difficulties with the rod breaking when hitting the tubes.".

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted report was sent in error.Bd is not responsible for complaint in investigation and reporting of this product.The complaint details have been forwarded to the supplier, aptaca.

Event Description

It was reported that 75000 bd aptaca urine cup 60 ml had the the transfer straws dislodge.The following information was provided by the initial reporter, translated from french to english: ".Very frequently difficulties with the rod breaking when hitting the tubes.".

• Brand Name: APTACA URINE CUP 60 ML
• Type of Device: TRANSPORT CULTURE MEDIUM
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16142870
• MDR Text Key: 307318656
• Report Number: 2243072-2023-00011
• Device Sequence Number: 1
• Product Code: JSM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 364931
• Device Lot Number: 220211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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