MAUDE Adverse Event Report: BECTON DICKINSON GMBH BD BBL¿ PLATE TSA 5PRCT SB 90MM; CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL

Catalog Number 254087

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Prolapse (2475)

Event Date 05/09/2023

Event Type  malfunction  

Event Description

It was reported that six bd bbl¿ plate tsa 5prct sb 90mm do not have the batch information printed on.The following information was provided by the initial reporter: customer noticed that 6 plates inside the stack don't have the batch number printed.Customer received 254087 batch 3010215, but they found 6 plates that don't have either the batch number or expiry date printed.Before use.

Manufacturer Narrative

H6 investigation summary: complaint history review: the complaints trends were reviewed, and one similar complaints were received on this catalog number; however, a trend could not be identified.Batch history record (bhr) review: the batch history review did not indicate any discrepancies.All release testing was satisfactory, and no deviations were observed.The in-process control for the print test was found to be without deviation.Sample analysis: retain samples were reviewed and no plate without a plate print could be identified.Physical samples were not returned for evaluation.However, picture samples were provided showing that the plate print on the bottom of the plate, which includes the batch number and expiry date, was missing.Evaluation results and investigation conclusion: at this stage of our investigation, we have excluded any systemic failure in our manufacturing process.Based on the evaluation of the provided pictures, and report, the complaint was confirmed for missing the plate print including the batch number and the expiry date.As no further complaints received of this defect, there are no corrective actions indicated at this time.However, bd will continue to monitor incoming complaints for this type of defect.H3 other text : see h.10.

• Brand Name: BD BBL¿ PLATE TSA 5PRCT SB 90MM
• Type of Device: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL
• Manufacturer (Section D): BECTON DICKINSON GMBH; 8-12 tullastrasse; heidelberg 69126 ; GM 69126
• Manufacturer (Section G): BECTON DICKINSON GMBH; 8-12 tullastrasse; heidelberg 69126 ; GM 69126
• Manufacturer Contact: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17043966
• MDR Text Key: 316883055
• Report Number: 9680577-2023-00024
• Device Sequence Number: 1
• Product Code: JSG
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: PREAMENDMENT
• 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
• Report Date: 05/17/2023

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: 04/17/2023
• Device Catalogue Number: 254087
• Device Lot Number: 3010215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2023
• Initial Date FDA Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2023
• 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