MAUDE Adverse Event Report: BECTON DICKINSON GMBH PLATE XLD AGAR 90MM 20; UNKNOWN

Catalog Number 254055

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 07/19/2022

Event Type  malfunction  

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 was reported that contamination was observed on the agar and inside the plates when plate xld agar 90mm 20 was received.This had an occurrence of 20.No patient impact was reported.The following information was provided by the initial reporter: contamination was observed on the agar and inside the plates when the product was received.On (b)(6) 2022/pw - clarification provided: "it was biological contamination, a colony/growth was detected on the plate at arrival.".

Event Description

It was reported that contamination was observed on the agar and inside the plates when plate xld agar 90mm 20 was received.This had an occurrence of 20.No patient impact was reported.The following information was provided by the initial reporter: contamination was observed on the agar and inside the plates when the product was received.(b)(6)2022/pw - clarification provided: "it was biological contamination, a colony/growth was detected on the plate at arrival.".

Manufacturer Narrative

H.6 investigation summary: complaint history review: the complaint history record for a period of 12 months has been checked and similar complaints related to this catalog number were recorded.However, no trend was 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.Sample analysis: the retain samples have been checked and no foreign matter could be detected on the plates no return samples were provided however the shared picture was illustrating the contamination on the plate evaluation results: at this stage of our investigation, we have excluded any systemic failure in our manufacturing process.Please note that this product does not have an sal (sterility assurance level) claim.It is filled aseptically, therefore an occurrence of a contamination event cannot be entirely ruled out.Please note that the valid standard for these products is din en 12322 "in vitro diagnostic medical devices - culture media for microbiology".According to this standard the contamination rate for each product lot must not exceed 4.9 %.Based upon our continuous monitoring, we derive a contamination rate that falls below this specified value.According to our high-quality standard, we only release product batches to the market with an aql (acceptable quality level) = 0,65.Investigation conclusion: based on the above-mentioned evaluation, the complaint can be confirmed.However, as no trend was identified, a corrective and preventive action will not be initiated.Bd regrets the inconvenience you have experienced and will continue to monitor incoming complaint with similar defects.

• Brand Name: PLATE XLD AGAR 90MM 20
• Type of Device: UNKNOWN
• 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 ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15601630
• MDR Text Key: 307097519
• Report Number: 9680577-2022-00108
• Device Sequence Number: 1
• Product Code: JSI
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/14/2022
• Device Catalogue Number: 254055
• Device Lot Number: 2143119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2022
• 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