SALEM SUMP 8888266130

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-09 for SALEM SUMP 8888266130 manufactured by Cardinal Health 200, Llc.

Event Text Entries

[144564825] Staff noted that the device is broken in the bag. No harm to the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8595060
MDR Report Key8595060
Date Received2019-05-09
Date of Report2019-05-01
Date of Event2019-04-29
Report Date2019-05-01
Date Reported to FDA2019-05-01
Date Reported to Mfgr2019-05-09
Date Added to Maude2019-05-09
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSALEM SUMP
Generic NameTUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
Product CodeFEG
Date Received2019-05-09
Model Number8888266130
Catalog Number8888266130
Lot Number1823331764
Device AvailabilityY
Device Age1 DA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCARDINAL HEALTH 200, LLC
Manufacturer Address785 FORT MILL HWY. FORT MILL SC 29707 US 29707


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-09

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