MAUDE Adverse Event Report: KIT PREPMATE CONSUME 480 TEST; PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED

Model Number	491455
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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 kit prepmate consume 480 test missing label information was observed by the laboratory personnel.There was no report of patient impact.The following information was provided by the initial reporter: " failure in one of the kit components (centrifuge tubes spare part #500024398) and illegible package batch".
Event or Problem Description
It was reported that while using kit prepmate consume 480 test missing label information was observed by the laboratory personnel.There was no report of patient impact.The following information was provided by the initial reporter: " failure in one of the kit components (centrifuge tubes spare part #500024398) and illegible package batch".
Additional Manufacturer Narrative
Investigation summary: the prepmate kit consumables kit 480 material number 491455, lot number 1131528 is intended for processing liquid-based cytology specimens collected in bd surepath collection vials.Each prepmate kit consumables kit 480 is intended to process 480 specimens, containing the following reagents/consumables: bd syringing pipettes, bd density reagent, centrifuge tubes, and aspirator tips.The bd instrument transfers each patient sample from the bd surepath collection vial into a centrifuge tube for further processing (cell enrichment) by density gradient centrifugation.The problem cited with the prepmate kit consumables kit 480 material number 491455, lot number 1131528, was for illegible packaged batch.The prepmate kit consumables kit 480 material number 491455, lot number 1131528 are manually packed at the mebane north carolina facility per the device history record 491460, title: dhr: bd d-cube consumables.Upon receipt per procedure 926-500024398 version b, rev.02, title: incoming inspection plane: bd centrifuge tubes 480/bag have a visual criteria; the visual inspection criteria attributes are the following: bag not damaged or dirty, bag sealed, bag labeled with correct label l 011187, bag contains current revision of label l011187, lot number is correct and present on label, label is legible, bag contains approximately 480 centrifuge tubes.Manufacturing batch history record review: the manufacturing batch history record for the prepmate kit consumables kit 480 material number 491455, lot number 1131528 was examined for related issues and no issues were found during the review.The certificate of analysis, and certificate of nonconformance for prepmate kit consumables kit 480 material number 491455, lot number 1131528 were reviewed ,no defects were noted.All qc inspections passed.One photo was provided for visual observation.From the photo provided showed one bd centrifuge tube bag material number 500024398 with what appears to be line creases on the label obscuring the lot number, confirming this complaint event.A retain inspection was performed on the remaining material housed at the mebane facility, and the complaint event was not found.Complaint history search: a complaint history check was conducted on the prepmate kit consumables kit 480 material number 491455, lot number 1131528, there were no other complaint found against that lot number or material number.H3 other text : see h10.

• Brand Name: KIT PREPMATE CONSUME 480 TEST
• Common Device Name: PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED
• MDR Report Key: 12628646
• Report Number: 3008007472-2021-00004
• Device Sequence Number: 19142333
• Product Code: MKQ
• UDI-Device Identifier: 00382904914554
• UDI-Public: 00382904914554
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P970018
• 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
• Report Date (Section B): 10/20/2021

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: 04/30/2023
• Device Model Number: 491455
• Device Catalogue Number: 491455
• Device Lot Number: 1131528
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/16/2021
• Supplement Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 11/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2021
• 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