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

Catalog Number 211677

Device Problem Contamination (1120)

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

Event Date 02/08/2022

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 the bd bottle bacto¿ peptone 500g was contaminated.There was no report of patient impact.The following information was provided by the initial reporter: customer reports contamination on product.

Event Description

It was reported that the bd bottle bacto¿ peptone 500g was contaminated.There was no report of patient impact.The following information was provided by the initial reporter: customer reports contamination on product.

Manufacturer Narrative

H6: investigation summary this memo is to summarize findings on the complaint related to bottle bacto peptone 500g, catalog number 211677, batch 1228037, and complaint #(b)(4) for unexpected smear on sds page coomassie gels.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 for the complaint batch.The batch history record review indicated no discrepancies.All release testing was satisfactory.Release testing consists of powder appearance, solubility and solution appearance of 2 and 10% solutions, 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 confirmed complaints on this lot.The customer stated that their media with the complaint peptone showed a smear on sds page coomassie gels.A photo of the prepared gel was provided with conclusion, ¿gibco peptone lot 1228037 (in use since (b)(6) 2021) is dirty¿.Bd does not test, monitor, or control for this customer¿s application.No historical data is available for performance of this media using sds page coomassie gels.Consequently, this complaint cannot be confirmed.H3 other text : see h10.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13664341
• MDR Text Key: 289254871
• Report Number: 1119779-2022-00357
• 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: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 211677
• Device Lot Number: 1228037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2021
• 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