MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) UNSPECIFIED BD CHOCOLATE AGAR PLATE; CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL

Catalog Number UNKNOWN

Device Problem Microbial Contamination of Device (2303)

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

Event Date 02/29/2024

Event Type  malfunction  

Manufacturer Narrative

There are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate sparks, md has been listed in sections d.3.And g.1.And the sparks, md fda registration number has been used for the manufacture report number.B.3.Date of event: unknown.The date received by manufacturer has been used for this field.D.4.Medical device expiration date: unknown h.4.Device manufacture date: unknown 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 when using an unspecified bd chocolate agar plate that mold contamination was found during incubation.The contamination was obvious to the healthcare worker and erroneous results were not reported.There was no health impact or consequence reported.

Event Description

It was reported when using an unspecified bd chocolate agar plate that mold contamination was found during incubation.The contamination was obvious to the healthcare worker and erroneous results were not reported.There was no health impact or consequence reported.

Manufacturer Narrative

H.6.Investigation summary: this memo is to summarize findings on your recent complaint pr (b)(4) with respect to contamination with mold.Event description: the customer reported there was mold on blood agar, chocolate agar, and can2 plates.Neither catalogue numbers nor lot numbers were given.Complaint history review: a specific complaint history review could not be performed in the absence of catalogue or lot numbers.However, a review of complaints from the past 12 months was performed for the reported defect.Similar complaints have been raised for plated media products.A trend was not identified.Batch history record (bhr) review: in the absence of lot numbers, a batch history record review cannot be performed.Sample analysis: as no lot numbers were given, no review of retainment samples could be performed.Pictures were not shared.Return samples were not available.Evaluation results: based on the investigation, no deviation could be detected in our validated manufacturing process.Review of retain samples or production records could not be performed since no lot numbers were provided.For products that are filled under aseptic conditions, sterility of the finished product cannot be guaranteed.Unfortunately, a 100 % inspection level for sterility is not possible and sterility testing is carried out based on a representative sample.In consequence, occasional contamination cannot be prevented by 100%; although the contamination rate remains below the acceptance level.A definite root cause was not identified.Investigation conclusion: based on the above-mentioned evaluation and the absence of samples or pictures, the complaint cannot be confirmed for contamination.Bd regrets the inconveniences you experienced and will continue to monitor similar incoming complaints.

• Brand Name: UNSPECIFIED BD CHOCOLATE AGAR PLATE
• Type of Device: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL
• Manufacturer (Section D): BECTON DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18988174
• MDR Text Key: 338765989
• Report Number: 1119779-2024-00234
• Device Sequence Number: 1
• Product Code: JSG
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 04/18/2024

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/27/2024
• Supplement Dates Manufacturer Received: 04/18/2024
• Supplement Dates FDA Received: 05/09/2024
• 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