MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD MAX¿ INSTRUMENT, REMANUFACTURED; INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS

Model Number	441927
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2022
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.Medical device expiration date: na.
Event or Problem Description
It was reported that bd max¿ instrument, remanufactured had incorrect label information.The following fields were corrected with additional information: "it was reported by the customer that the box was labeled correctly with the incorrect part inside.".
Event or Problem Description
It was reported that bd max¿ instrument, remanufactured had incorrect label information.The following fields were corrected with additional information: "it was reported by the customer that the box was labeled correctly with the incorrect part inside.".
Additional Manufacturer Narrative
After additional review, this mfr# 1119779-2022-00346 was submitted in error.This is not a reportable event.This mdr should be considered canceled.
Additional Manufacturer Narrative
H.6 investigation summary a complaint of "calibration plate ¿ incorrect pack out (spf)" was received against instrument max clinical refurb material number: 441927, serial number: (b)(6).A bd field service engineer was dispatched.Plate calibration 6 color was replaced to resolve the issue.Instrument was found to be functional and released to the customer for regular use.This complaint is a confirmed failure of the bd product based on the service investigation.The root cause was unable to be determined as no materials were received for investigation.Dhr review for the instrument (b)(6), is not required for this complaint.The complaint was evaluated via other elements of the investigation.The results of this evaluation have not identified any new hazards, new risks, or specific trends.Service history review revealed no previous complaints for this issue.Samples were not received by quality for investigation and thus, returned material investigation could not occur.No new trends, risks, or hazards were identified as a result of the complaint.Bd quality will continue to closely monitor for trends associated with this complaint.
Event or Problem Description
It was reported that bd max¿ instrument, remanufactured had incorrect label information.The following fields were corrected with additional information: "it was reported by the customer that the box was labeled correctly with the incorrect part inside.".

• Brand Name: BD MAX¿ INSTRUMENT, REMANUFACTURED
• Common Device Name: INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS
• 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: 13656881
• Report Number: 1119779-2022-00346
• Device Sequence Number: 19318825
• Product Code: OOI
• UDI-Device Identifier: 00382904419271
• UDI-Public: 00382904419271
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K111860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/11/2022

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: 441927
• Device Catalogue Number: 441927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2022
• Supplement Date Received by Manufacturer: 07/21/2022; 08/11/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 08/10/2022; 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2017
• Is the Device Labeled for Single Use? (Y/N): No
• 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