APTIMA MULTITEST COLLECTION TUBES PRD-03546

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2017-05-24 for APTIMA MULTITEST COLLECTION TUBES PRD-03546 manufactured by Hologic, Inc..

Event Text Entries

[75855597] Hologic did not know the impact of the pileless caps until testing results from 4/24/2017. This report is submitted within 30 days from hologic's awareness of positive testing results. Based on those initial results, additional testing was required to determine the final reportability decision.
Patient Sequence No: 1, Text Type: N, H10


[75855598] The customer, (b)(6), reported an observation of aptima multitest collection tubes that did not contain the cotton layer (pile) within the penetrable cap. The customer continued analysis with specimen tubes from an alternative unaffected lot. Review of the returned items revealed that the lack of a cotton layer is not the result of damage or misuse. The foil seals on the affected tubes returned to site were intact, and when opened the cotton layer was found to be missing. It was concluded that the affected tubes have been manufactured with caps that did not contain the cotton layer. It was determined the incorrect cap (pn 502212) was used to manufacture a small number of mutltitest tubes, pn ffl-00421 ln 184791h.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2024800-2017-00015
MDR Report Key6587710
Report SourceFOREIGN
Date Received2017-05-24
Date of Report2017-05-24
Date of Event2017-03-24
Date Mfgr Received2017-03-24
Date Added to Maude2017-05-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS JULIETTE BUSSE
Manufacturer Street10210 GENETIC CENTER DR
Manufacturer CitySAN DIEGO CA 92121
Manufacturer CountryUS
Manufacturer Postal92121
Manufacturer Phone8584108799
Manufacturer G1HOLOGIC, INC
Manufacturer Street10210 GENETIC CENTER DR
Manufacturer CitySAN DIEGO CA 92121
Manufacturer CountryUS
Manufacturer Postal Code92121
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAPTIMA MULTITEST COLLECTION TUBES
Generic NameIN VITRO DIAGNOSTICS
Product CodeLSL
Date Received2017-05-24
Catalog NumberPRD-03546
Lot Number185654H
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerHOLOGIC, INC.
Manufacturer Address10210 GENETIC CENTER DR. SAN DIEGO CA 92121 US 92121


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-05-24

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