MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BOTTLE BACTO PEPTONE 500G

Catalog Number 211677

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

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

Event Date 10/14/2021

Event Type  malfunction  

Manufacturer Narrative

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 testing with 4 bd bottle bacto peptone 500g there was atypical growth.The following information was provided by the initial reporter: it was reported that there is atypical growth.

Event Description

It was reported that while testing with 4 bd bottle bacto peptone 500g there was atypical growth.The following information was provided by the initial reporter: it was reported that there is atypical growth.

Manufacturer Narrative

H6: investigation summary this memo is to summarize findings on the complaint related to bottle bacto peptone 500g, catalog number 211677, batch 1123046, and complaint #3779516 for performance.Components are milled and blended (where required), and dispensed into containers.Following qc release, and based upon inventory demand, final packaging operations occur, which include dispensing into and labeling of final configurations, followed by transport to the distribution center.The complaint investigation included a review of the batch history record.The batch history record review indicated no discrepancies.All release testing was satisfactory.Release testing consists of powder appearance, solubility of 2 and 10% solutions, 2 and 10 % prepared solution appearance, residual solvents, ph, loss on drying, ash, nitrogen, amino nitrogen and growth promotion with organisms specified on the bd certificate of analysis.The complaint trends were reviewed for a period covering 12 months.During that time, there have been no other complaints on this product for performance defects.No returns or photos were received for the investigation.A retention sample from the complaint batch was tested for escherichia coli, atcc 25922 and staphylococcus aureus, atcc 25923 performance against a reference batch of bacto peptone.For performance testing, the peptone samples are combined with agar and salt to prepare an agar media per test instructions, then ph is adjusted as necessary.Samples are then boiled for one minute to dissolve, autoclaved at 121°c for 15 minutes then placed in a 45-50°c waterbath to cool.Upon cooling, plates are poured and allowed to solidify.Plates are streaked with cultures, 30-300 cfu per inoculum then incubated at 33-37°c for 42-48 hours.Satisfactory performance is good recovery.All samples were satisfactory; retention had comparable growth and colony size to the reference for both coa organisms.The uninoculated plates remained negative.Per the customer complaint intake, growth promotion issues are being observed with c.Albicans.The customer states that the organism should remain in the "yeast form" under normal conditions, but filamentation is observed with this organism when using lot 1123046 of material 211677.Bd does not maintain claims or performance data for this organism with bacto peptone.Consequently, this complaint cannot be confirmed.

• Brand Name: BD BOTTLE BACTO PEPTONE 500G
• 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: 12800528
• MDR Text Key: 281663558
• Report Number: 1119779-2021-01806
• Device Sequence Number: 1
• Product Code: PPM
• 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: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 211677
• Device Lot Number: 1123046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2021
• 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