MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ CDC ANAEROBE 5% SHEEP BLOOD AGAR WITH PHENYLETHYL ALCOHOL (PEA); CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL

Model Number 221739

Device Problem Inaccurate Information (4051)

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

Event Date 01/17/2022

Event Type  malfunction  

Event Description

It has been reported that the bd bbl¿ cdc anaerobe 5% sheep blood agar with phenylethyl alcohol (pea) has been found experiencing 100 occurrences of incorrect label information.The following has been provided by the initial reporter: content does not match label (outer label is cdc w/pea 221739; content is bhi).

Manufacturer Narrative

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 has been reported that the bd bbl¿ cdc anaerobe 5% sheep blood agar with phenylethyl alcohol (pea) has been found experiencing 100 occurrences of incorrect label information.The following has been provided by the initial reporter: content does not match label.(outer label is cdc w/pea 221739; content is bhi).

Manufacturer Narrative

H.6 investigation summary: complaint investigation.During manufacturing of material 221739, media is formulated and sent through a high temperature short time sterilizer to remove bioburden.The petri dishes are subjected to uv radiation to decrease bioburden.The petri dishes are filled in a positive pressure hepa filtered environment.The filled plates are cooled and immediately wrapped into sleeves to decrease the introduction of microbes.Sleeves are then packaged into cartons and then transferred to a refrigerated truck (2 to 8 degrees c) for shipment to the distributor.Bd distributors are provided with the storage guidelines for the shipping and handling of bd media of 2 to 8 degrees c in a dark place.The batch history record for batch 1333722 was satisfactory and no quality notifications were generated during manufacturing and inspection.Qc inspection and testing were satisfactory at time of release.The complaint history was reviewed, and no other complaints have been taken on batch 1333722.Retention samples from batch 1333722 were not available for inspection.Four photos were received for investigation.Two photos each show the top of an opened sleeve that appears to have a plate of bhi media on the top.One photo shows the top of an opened sleeve with what appears to be a plate of bhi media on top; the plate print is blurry.The last photo features a sleeve label from batch 1333722 for batch verification.No returns were received for investigation of this complaint.The customer describes a plate of bhi media in a sleeve of cdc anaerobe with pea (material 221739).Bd acknowledges the observation and photos provided by the customer.Batch 1333722 was manufactured on december 02, 2021 in the sparks, md plant.Plates of material 221739 are packaged into sleeves and cartons via an automated process.Sleeve labeling and carton labeling are also part of the automated packaging process for this product.Review of the manufacturing records show no interventions during the packaging process of batch 1333722.Additionally, manufacturing records were reviewed, and no bhi media products were manufactured in the plant in the ten days prior to or ten days after manufacture of batch 1333722.An incident of a packaging or labeling defect for batch 1333722 is not supported by the manufacturing records.Shipping records indicate batch 1333722 was shipped to customers worldwide and no other complaints have been taken on batch 1333722.This complaint cannot be confirmed.Bd will continue to trend complaints for packaging.Risk management file review assessed the potential risk for the defect as severity s1 per baltrmppmselectiveaph, rev 02, id 6.4.

• Brand Name: BD BBL¿ CDC ANAEROBE 5% SHEEP BLOOD AGAR WITH PHENYLETHYL ALCOHOL (PEA)
• Type of Device: CULTURE MEDIA, 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13386345
• MDR Text Key: 288869468
• Report Number: 1119779-2022-00144
• Device Sequence Number: 1
• Product Code: JSJ
• UDI-Device Identifier: 10382902217395
• UDI-Public: 10382902217395
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K803027
• 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: 12/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/10/2022
• Device Model Number: 221739
• Device Catalogue Number: 221739
• Device Lot Number: 1333722
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2021
• 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