MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD RODAC¿ SNAP LID TRYPTICASE¿ SOY AGAR (TSA) W LECITHIN & POLYSORBATE 80

Catalog Number 215285

Device Problem Missing Information (4053)

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

Event Date 09/29/2021

Event Type  malfunction  

Event Description

It was reported that while using bd rodac¿ snap lid trypticase¿ soy agar (tsa) w lecithin & polysorbate 80, missing label information was observed twice.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the customer that the label fell off.

Manufacturer Narrative

Initial reporter addr: (b)(6).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 bd rodac¿ snap lid trypticase¿ soy agar (tsa) w lecithin & polysorbate 80, missing label information was observed twice.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the customer that the label fell off.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-10-11.H6: investigation summary : this statement is to summarize findings regarding the complaint related to catalog number 215285, plate ster isol tsa lp80 rodac snap 100 ea, for batch number 1182713 for labeling.Material 215285 is manufactured by rehydrating the dehydrated culture media (dcm) with usp purified water.The media is then processed through a high temperature short time sterilizer to remove bioburden and is aseptically dispensed directly into rodac dishes.The rodac dishes are then sealed into clean sleeves and boxed.Personnel working in the filling area are required to wear full body jumpsuits, hoods, boots, masks and gloves.The filled plates are cooled and immediately wrapped to decrease the introduction of microbes.Dispensing and sleeving are completed within an iso certified environment.Sleeved plates are loaded into cartons and then cartons are transferred to a refrigerated truck (2 to 8 degrees c) for shipment to the irradiator, product is then shipped to bd customers and distributors via refrigerated truck.Bd distributors are provided with the storage guidelines for the shipping and handling of bd media 2 to 8 degrees c in a dark place.The batch history review for batch 1182713 was satisfactory and no quality notifications were generated during manufacturing and inspection.The release testing that is performed on this product does include physical attribute testing.A sample of plates are tested for physical attributes prior to release to ensure that they conform to product specifications.All physical attribute testing performed on this batch was satisfactory per bd internal procedures.The complaint history was reviewed, and no other complaints have been taken on batch 1182713.Retention samples from batch 1182713 were available for inspection.Thirty plates from three unopened sleeves were inspected and 7/30 plates had labels that were peeling away from the plate (sn range (b)(6) to (b)(6)).Returns were received for investigation.One unopened sleeve (10 plates) from batch 1182713 were returned in a box with bubble wrap (sn (b)(6) to (b)(6)).Plates were inspected and 10/10 plates each had the label peeing away from the side of the plate.One photo also was received for investigation.The photo shows a stack of plates from batch 1182713 in a bag with one plate where the label is falling off the side of the plate (sn (b)(6)).This complaint has been confirmed.Bd has identified a label adhesion issue, affecting the plate labels on sterile ppm products, where the label face is separating from the adhesive layer.The bd label supplier continues to investigate the root cause of the label failure.The label supplier has provided an equivalent white plate label to use with this product, 215285, with a stronger adhesive.There are no dimensional changes and the finished top coat remains the same.This equivalent label was put into production starting july 02, 2021.Batch 1182713 was manufactured on july 25, 2021.The purge of defect labels prior to use of the alternative was found to be incomplete.However, no defective labels were used in production of batches after september 2021.Bd does not expect any further label issues in batches with the usage of the alternative label.

• Brand Name: BD RODAC¿ SNAP LID TRYPTICASE¿ SOY AGAR (TSA) W LECITHIN & POLYSORBATE 80
• Type of Device: NA
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12701330
• MDR Text Key: 284883997
• Report Number: 1119779-2021-01719
• Device Sequence Number: 1
• Product Code: JSG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/14/2022

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: 12/04/2021
• Device Catalogue Number: 215285
• Device Lot Number: 1182713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2021
• Initial Date FDA Received: 10/26/2021
• Supplement Dates Manufacturer Received: 01/14/2022
• Supplement Dates FDA Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2021
• 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