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

Catalog Number 442023

Device Problem Inaccurate Information (4051)

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

Event Date 07/13/2023

Event Type  malfunction  

Manufacturer Narrative

E.6 initial reporter e-mail: (b)(6).G.6 pma / 510(k)#: k113558, k222591.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that while using the bd bactec¿ plus aerobic/f culture vials (plastic) that there is incorrect label information.The following information was provided by the initial reporter: 1.Have instrument log files been obtained and reviewed? -- i do not have instrument log files.2.Has an application specialist reached out to the customer to review customer workflow? -- yes and all is normal we have the same case for 5 other sequence number.The customer entered a first vial with sequence number (b)(4) from lot 3062849 exp date 08/12/2023 on (b)(6) 2023 at 10:54.And then he entered a second vial with the same sequence number (b)(4) from lot 3062849 exp date 08/12/2023 on (b)(6) 2023 at 20:44.The customer doesn't understand how it's possible to have the same bottle sequence number twice in the same batch.

Manufacturer Narrative

H.6.Investigation summary: catalog 442023, batch no.3062849.Customer reported a duplicated barcode sequences within the same batch numbers.Satisfactory results were obtained from retention samples when visually inspected for repeated sequence (none of the vial label sequence numbers were repeated).Batch history record was reviewed.A complaint history review was conducted and only the current complaint was found relating the incident to the lot number.Complaints is confirmed.Users should verify that the accession number on the bd bactec¿ instrument loading screen matches the vial's accession number while scanning and loading onto the instrument.If an error message or other system action occurs when loading vials into the bd bactec¿ instrument that indicates a potential issue with duplicate sequence numbers, it is recommended to follow the instructions within the message and to view the table of ¿system alerts¿ located in 7 ¿ troubleshooting of the bd bactec¿ fx instrument user¿s manual before taking any further action in vial processing.Refer to product advisory notification.Corrective actions preventive actions (capa) was initiated to determine any appropriate actions to reduce occurrence.A cross functional team continually monitors all product complaints for trends and determines if any additional actions are necessary beyond the current investigational process.

Event Description

It was reported that while using the bd bactec¿ plus aerobic/f culture vials (plastic) that there is incorrect label information.The following information was provided by the initial reporter: 1.Have instrument log files been obtained and reviewed? -- i do not have instrument log files.2.Has an application specialist reached out to to the customer to review customer workflow? -- yes and all is normal we have the same case for 5 other sequence number.The customer entered a first vial with sequence number 449270866677 from lot 3062849 exp date 08/12/2023 on 07/07/2023 at 10:54.And then he entered a second vial with the same sequence number 449270866677 from lot 3062849 exp date 08/12/2023 on 07/07/2023 at 20:44.The customer doesn't understand how it's possible to have the same bottle sequence number twice in the same batch.

• 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: 17421346
• MDR Text Key: 321334629
• Report Number: 2647876-2023-00089
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904420239
• UDI-Public: 00382904420239
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K113558
• 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: 09/26/2023

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: 12/08/2023
• Device Catalogue Number: 442023
• Device Lot Number: 3062849
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2023
• Initial Date FDA Received: 07/28/2023
• Supplement Dates Manufacturer Received: 09/25/2023
• Supplement Dates FDA Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2023
• 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