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

Catalog Number 442288

Device Problems Break (1069); Leak/Splash (1354)

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

Event Date 11/03/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).There were multiple 510k numbers reported to be involved.The information for the additional 510k is as follows: pma / 510(k)#: k970333.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 testing with bd bactec¿ myco/f lytic culture vials the bottle broke with (b)(6) sample inside.There was no report of patient or user impact.The following information was provided by the initial reporter: glass bottle breakage with (b)(6) sample inside.

Manufacturer Narrative

Investigation summary: bd was unable to reproduce customer¿s experience with bactec product.Photo was not provided.Satisfactory results were obtained from retention samples when visually inspected for bottle integrity (i.E.Broken/cracked bottles).Batch history record review did not identify any evidence for which the customer submitted the complaint.A complaint history review was conducted and only the current complaint was found relating to the incident lot number and the ¿as reported¿ defect code.Complaint is unconfirmed based on retention samples and batch history record review results.The controls in place to detect this type of defect are: a 100% visual inspection performed during the packaging process in order to detect bottle damage.Also, during the packaging process of each lot, a process control representative inspects 1 case every 30 minutes for completeness.Product insert warning and precautions states that prior use, the user should examine the vials for evidence of damage or deterioration.No corrective actions were required.A cross functional team continually monitors all product complaints for trends and determines if any additional actions are necessary beyond the current investigation process.H3 other text : see h10.

Event Description

It was reported that while testing with bd bactec¿ myco/f lytic culture vials the bottle broke with positive tb sample inside.There was no report of patient or user impact.The following information was provided by the initial reporter: glass bottle breakage with tb positive sample inside.

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12911552
• MDR Text Key: 285644206
• Report Number: 2647876-2021-00304
• Device Sequence Number: 1
• Product Code: MDB
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 442288
• Device Lot Number: 1055279
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2021
• 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