MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ SENSI-DISC¿ FOSFOMYCIN -200 ¿G; SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL

Model Number	231709
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.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 while using bd bbl¿ sensi-disc¿ fosfomycin -200 g missing label information was observed by the laboratory personnel.The customer stated there was no patient impact.The following information was provided by the initial reporter: "declaration of glucose-6-phosphat is missing in ifu.".
Event or Problem Description
It was reported that while using bd bbl¿ sensi-disc¿ fosfomycin -200 g missing label information was observed by the laboratory personnel.The customer stated there was no patient impact.The following information was provided by the initial reporter: "declaration of glucose-6-phosphat is missing in ifu.".
Additional Manufacturer Narrative
H6: investigation summary: a complaint investigation due to missing "glucose-6-phosphate" wording on product fosfomycin 200 was performed.Evaluation of returned goods and retention samples is not required since this customer claim is related to documentation in product insert.The investigation required to evaluate product insert for fosfomycin 200 products.It was observed that product insert does not include the wording of glucose-6-phosphate".Labeling design group was contacted for insert revision.No additional corrective action is required.Compliant is confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The investigation required to evaluate ifu.Ifu evaluated and it was observed that wording "glucose-6-phosphate" was not referenced.

• Brand Name: BD BBL¿ SENSI-DISC¿ FOSFOMYCIN -200 ¿G
• Common Device Name: SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL
• 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: 13161236
• Report Number: 1119779-2021-02080
• Device Sequence Number: 19853533
• Product Code: JTN
• UDI-Device Identifier: 00382902317098
• UDI-Public: 00382902317098
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K972098
• 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): 01/21/2022

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 Model Number: 231709
• Device Catalogue Number: 231709
• Device Lot Number: UNKNOWN
• 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: 12/08/2021
• Supplement Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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