MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ LOWENSTEIN-JENSEN MEDIUM SLANTS 100 EA.; CULTURE MEDIA, ENRICHED

Model Number	220909
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter email: (b)(6).H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd bbl¿ lowenstein-jensen medium slants 100 ea.Had various ph variations.The following information was provided by the initial reporter: along with greetings, i would like through this medium to expose the situation that occurred with culture media, which, as indicated in the attached invoice, were purchased in the month of november of the year 2022, for which reason we recently opened the remaining boxes (4 boxes) to carry out control.Of quality, and we found that almost all of the boxes had ph variations (see attached image, here you can see tubes with ph variations on the left hand side and normal tubes on the right hand side), of the 400 tubes it was possible to rescue 75.We reviewed the traceability of the temperatures in the cabinet where the culture media are stored and there have been no variations.Therefore, we associate it with manufacturing quality problems.
Additional Manufacturer Narrative
H.6.Investigation summary: material 220909 is manufactured by rehydrating the media components with usp purified water and thoroughly mixing until a homogeneous solution is obtained.The tubes are filled, capped, torqued, and then labeled by machine per standard operating procedure (sop).The tubes are then packed into trays and loaded onto a slant rack cart.The loaded cart is then run on a set inspissation cycle per sop.Post inspissation, tubes are packaged into final shipping configurations.The batch history record review for batch 2188063 was satisfactory and no quality notifications were generated during manufacturing and inspection.Filling, torquing, and autoclaving processes were within specifications.In process checks during packaging were performed according to procedures.Qc inspection and testing were satisfactory at time of release.The complaint history for this batch was reviewed and no other complaints have been taken on this batch.Retention samples from batch 2188063 (10 tubes) were available for inspection.A carton of 10 tubes showed no evidence of media defects from visual inspection.For further investigation of performance testing, the ph was tested on four retention tubes.The ph did vary from tube to tube.The ph range measured from 7.03-7.35 with an average ph rating of 7.145 the temperature taken on each retention tube ranged from about 25-26-degrees celsius.The average ph was within specifications in accordance with the certificate of analysis.For additional investigation performance testing for growth of mycobacterium organisms was performed according to qc procedures.All performance testing was satisfactory and in accordance with the certificate of analysis.One photo was received to assist with the investigation.No returns were received to assist with the investigation.This complaint cannot be confirmed for a performance defect.No complaint trends for this defect have been identified for this product; no actions are indicated at this time.Bd will continue to trend complaints for performance issues.Ph can vary with temperature.Always check the ph equipment used during qc checks to ensure the equipment is functioning properly.H3 other text : see h.10.
Event or Problem Description
It was reported that bd bbl¿ lowenstein-jensen medium slants 100 ea.Had various ph variations.The following information was provided by the initial reporter: along with greetings, i would like through this medium to expose the situation that occurred with culture media, which, as indicated in the attached invoice, were purchased in the month of november of the year 2022, for which reason we recently opened the remaining boxes (4 boxes) to carry out control.Of quality, and we found that almost all of the boxes had ph variations (see attached image, here you can see tubes with ph variations on the left hand side and normal tubes on the right hand side), of the 400 tubes it was possible to rescue 75.We reviewed the traceability of the temperatures in the cabinet where the culture media are stored and there have been no variations.Therefore, we associate it with manufacturing quality problems.

• Brand Name: BD BBL¿ LOWENSTEIN-JENSEN MEDIUM SLANTS 100 EA.
• Common Device Name: CULTURE MEDIA, ENRICHED
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17083534
• Report Number: 1119779-2023-00623
• Device Sequence Number: 16687690
• Product Code: KZI
• UDI-Device Identifier: 30382902209097
• UDI-Public: 30382902209097
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2023

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
• Operator of Device: Other
• Device Expiration Date: 12/31/2023
• Device Model Number: 220909
• Device Catalogue Number: 220909
• Device Lot Number: 2188063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2023
• Supplement Date Received by Manufacturer: 10/16/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 10/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown