MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS; SYSTEM, BLOOD CULTURING

Catalog Number 442288

Device Problem Leak/Splash (1354)

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

Event Date 08/03/2023

Event Type  malfunction  

Manufacturer Narrative

D.4.Medical device lot #: unknown; d.4.Medical device expiration date: unknown; e.1.Initial reporter phone #: (b)(6); g.5.K970333; h.4.Device manufacture date: unknown.H.6.Investigation summary: catalog 442288; batch no.Unknown.Customer reported a contaminated bottle fell on the floor and broke.Neither photos nor returned good samples were received.Bd was not able to perform an investigation to the retention samples since batch number is unknown.A complaint history review cannot be conducted relating to the incident lot number and the ¿as reported¿ defect code since batch number is unknown.The batch history record could not be reviewed as the lot number is unknown nonetheless batch history records are always reviewed prior to product release.Complaint is unconfirmed.No correctives actions were required.H3 other text : see h.10.

Event Description

Report 1 of 2 it was reported that while using bd bactec¿ myco/f lytic culture vials, one bottle containing patient sample fell on the floor.One end user was not wearing ppe, however, has tested negative on quantiferon exams.No additional impact reported.The following information was provided by the initial reporter: "bd bactec myco/f glass bottle, positive for mycobacterium tuberculosis, fell to the floor and broke when removed from the equipment.No ppe was being used at the time.However, in the sequence, they put on an n95 mask and gloves to be able to contain the liquid with absorbent paper.The collaborators are being assisted by the occupational medicine and underwent x-ray and quantiferon exams.One of them has negative tests.".

• Brand Name: BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS
• Type of Device: SYSTEM, BLOOD CULTURING
• Manufacturer (Section D): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer (Section G): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17560986
• MDR Text Key: 321318950
• Report Number: 2647876-2023-00099
• Device Sequence Number: 1
• Product Code: MDB
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K970512
• 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
• Report Date: 08/12/2023

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
• Device Operator: Other
• Device Catalogue Number: 442288
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2023
• Initial Date FDA Received: 08/16/2023
• 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