ISOLATOR 1.5 ML MICROBIAL TUBES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-08-02 for ISOLATOR 1.5 ML MICROBIAL TUBES manufactured by .

Event Text Entries

[2202489] Customer reported on (b)(6) 2011 that a blood culture tube shattered when inoculated with blood on (b)(6) 2011. Blood splattered over wall and 2 people. No other injuries to the 2 people involved due to shattering (glass did not puncture skin).
Patient Sequence No: 1, Text Type: D, B5


[9400734] Lot 031422 was manufactured on 11/17/2010 and consisted of (b)(4). (b)(4). There was one defect noted for a broken tube during the assembly operation. No tubes were broken during the testing process. There were no internal rejects associated with this lot of production. Investigation: no samples were returned for investigation. The defect could not be confirmed. If a defect condition is detected, product would have been rejected and dispositioned appropriately. This is the only event of this nature for this lot.
Patient Sequence No: 1, Text Type: N, H10


[6348999] Customer reported on (b)(6) 2011 that a blood culture tube shattered when inoculated with blood on (b)(6) 2011. Blood splattered over wall and 2 people. No other injuries to the 2 people involved due to shattering (glass did not puncture skin).
Patient Sequence No: 2, Text Type: D, B5


[14087099] Lot 031422 was manufactured on 11/17/2010 and consisted of (b)(4). (b)(4). There was one defect noted for a broken tube during the assembly operation. No tubes were broken during the testing process. There were no internal rejects associated with this lot of production. Investigation: no samples were returned for investigation. The defect could not be confirmed. If a defect condition is detected, product would have been rejected and dispositioned appropriately. This is the only event of this nature for this lot.
Patient Sequence No: 2, Text Type: N, H10


MAUDE Entry Details

Report Number1221359-2011-00002
MDR Report Key2214067
Report Source07
Date Received2011-08-02
Date of Report2011-08-02
Date of Event2011-06-28
Date Mfgr Received2011-06-29
Device Manufacturer Date2010-11-01
Date Added to Maude2012-06-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactEMILY DEANE, SR. MGR.
Manufacturer Street10 SOUTHGATE RD.
Manufacturer CitySCARBOROUGH ME 04074
Manufacturer CountryUS
Manufacturer Postal04074
Manufacturer Phone2077305750
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameISOLATOR 1.5 ML MICROBIAL TUBES
Generic NameNONE
Product CodeLIO
Date Received2011-08-02
Lot Number031422
Device Expiration Date2012-10-31
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2011-08-02
201. Other 2011-08-02

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