MAUDE Adverse Event Report: BECTON DICKINSON GMBH BD BBL¿ HAEMOPHILUS TEST MEDIUM AGAR (HTM AGAR) 2PREPARED MEDIA

Catalog Number 254058

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

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

Event Date 10/20/2021

Event Type  malfunction  

Event Description

It was reported that while using bd bbl¿ haemophilus test medium agar (htm agar) there was a performance issue resulting in no growth. This was the only stated occurrence. No additional testing was mentioned. There was no indication that results were reported out, and there was no patient impact. The following information was provided by the initial reporter: update 10/25/2021: was this with patient samples or qc? patient. If patient samples - need to know if there was any erroneous results and if so - were any reported out on the patients. Were they treated based on the erroneous results? no erroneous result reported. Did this lot work previously? it was first time this customer receives this lot. Haemophilus for disc difussion does not grow.

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete. Upon completion, a supplemental report will be filed. There is no 510(k) for this device as it is manufactured outside the us and not sold in the us but is considered to be substantially similar to the legally u. S. Marketed device bd bbl¿ haemophilus test medium agar (htm agar) catalog number 221954 which has 510k number k894216b.

• Brand Name: BD BBL¿ HAEMOPHILUS TEST MEDIUM AGAR (HTM AGAR)
• Type of Device: 2PREPARED MEDIA
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12817136
• MDR Text Key: 285352032
• Report Number: 9680577-2021-00079
• Device Sequence Number: 1
• Product Code: JSO
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K894216B
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/22/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/08/2021
• Device Catalogue Number: 254058
• Device Lot Number: 1257478
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial