MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC); SYSTEM, BLOOD CULTURING

Catalog Number 442023

Device Problem Leak/Splash (1354)

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

Event Date 07/11/2023

Event Type  malfunction  

Manufacturer Narrative

G5.Pma/510k info: k113558, k222591.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that before using bd bactec¿ plus aerobic/f culture vials (plastic) the stopper was defective and leaking occurred from a dented rubber stopper.This issue occurred with 3 bottles and no patient impact was reported.The following information was provided by the initial reporter: what type of defective rubber stopper? leaking from a dented rubber stopper.When was issue detected? prior to use or after use? found before use.The rubber stopper was defective and the contents of the blood bottle leaked out.

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted report 3008352382-2023-00112 was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore this is not considered to be a reportable malfunction.

Event Description

It was reported that before using bd bactec¿ plus aerobic/f culture vials (plastic) the stopper was defective and leaking occurred from a dented rubber stopper.This issue occurred with 3 bottles and no patient impact was reported.The following information was provided by the initial reporter: what type of defective rubber stopper? -- leaking from a dented rubber stopper.When was issue detected? prior to use or after use? -- found before use.The rubber stopper was defective and the contents of the blood bottle leaked out.

• Brand Name: BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)
• 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: 17425763
• MDR Text Key: 320247728
• Report Number: 3008352382-2023-00112
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904420239
• UDI-Public: 00382904420239
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: SEE H.10
• 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: 08/21/2023

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 Expiration Date: 10/27/2023
• Device Catalogue Number: 442023
• Device Lot Number: 3019563
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2023
• Initial Date FDA Received: 07/31/2023
• Supplement Dates Manufacturer Received: 08/21/2023
• Supplement Dates FDA Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1