PLUER-EVAC SAHARA RAPID TRANSFER BAG 10/BX

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2014-04-28 for PLUER-EVAC SAHARA RAPID TRANSFER BAG 10/BX manufactured by Teleflex Medical.

Event Text Entries

[4525189] Complaint alleges: during a re-infusion procedure, the rns (registered nurses) said they squeezed the bags repeatedly but the blood did not seem to flow. The bags filled easily, but they had trouble getting the blood out of the bag. Additional information received: the pt was getting transfused due to acute blood loss from a gunshot wound to the chest. The pt is deceased. The medical interventions performed were: chest thoracotomy, blood transfusions, chest tube, iv fluids.
Patient Sequence No: 1, Text Type: D, B5


[11904060] The device history record has been reviewed and no issues or discrepancies were found, which could potentially relate to this complaint. No rejection report was originated for the lot in question that can be associated to the complaint reported. Dhr shows that the product was assembled and inspected according to our specifications. A history review was conducted for similar complaints for catalog #s-250-08, and no previous complaints were found that relate to the reported issue. Device sample received by manufacturer, but investigation is still underway at time of this report.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3004365956-2014-00163
MDR Report Key3804468
Report Source05,06,07
Date Received2014-04-28
Date of Report2014-03-31
Date of Event2014-03-26
Date Mfgr Received2014-03-31
Device Manufacturer Date2012-07-01
Date Added to Maude2014-05-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactJASMINE BROWN
Manufacturer StreetPO BOX 12600
Manufacturer CityDURHAM NC 27709
Manufacturer CountryUS
Manufacturer Postal27709
Manufacturer Phone9193614124
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePLUER-EVAC SAHARA RAPID TRANSFER BAG 10/BX
Generic NameTRANSFER BAG
Product CodePAD
Date Received2014-04-28
Returned To Mfg2014-04-15
Lot Number02G1202875
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressNUEVO LAREDO MX


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2014-04-28

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.