MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PHOENIXSPEC¿ AP CALIBRATOR KIT; NEPHELOMETER, FOR CLINICAL USE

Model Number	441951
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 phoenixspec¿ ap calibrator kit an incorrect expiration date was observed by the laboratory personnel.There was no report of patient impact.The following information was provided by the initial reporter: "client has received a new calibrator with expiry date : 15apr2020.".
Event or Problem Description
It was reported that while using bd phoenixspec¿ ap calibrator kit an incorrect expiration date was observed by the laboratory personnel.There was no report of patient impact.The following information was provided by the initial reporter: "client has received a new calibrator with expiry date : 15apr2020".
Additional Manufacturer Narrative
After further evaluation, it was determined that the previous mfr report # 1119779-2021-01725 was submitted in error.This event has been determined to be a service organization error and is not considered a reportable event.This mdr is to be considered canceled.

• Brand Name: BD PHOENIXSPEC¿ AP CALIBRATOR KIT
• Common Device Name: NEPHELOMETER, FOR CLINICAL USE
• 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: 12704406
• Report Number: 1119779-2021-01725
• Device Sequence Number: 17103081
• Product Code: JQX
• UDI-Device Identifier: 00382904419516
• UDI-Public: 00382904419516
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: EXEMPT
• 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): 03/04/2022

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 Expiration Date: 04/15/2020
• Device Model Number: 441951
• Device Catalogue Number: 441951
• Device Lot Number: 9127944
• 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: 09/29/2021
• Supplement Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 10/27/2021
• Supplement Report FDA Received Date: 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2019
• 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