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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PFM MEDICAL, INC ASEPT 1,000ML DRAINAGE BOTTLE; BOTTLE COLLECTION, VACUUM
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PFM MEDICAL, INC ASEPT 1,000ML DRAINAGE BOTTLE; BOTTLE COLLECTION, VACUUM Back to Search Results
Catalog Number M7050
Device Problem Suction Problem (2170)
Patient Problem Aspiration/Inhalation (1725)
Event Date 12/04/2013
Event Type  malfunction  
Event Description
Event desc: our facility has been ordering the b braun empty evacuated container for phlebotomies (blood letting) and other procedures.B braun has placed this item on an allocation with our vendor.The replacement item they recommended is the asept 1000ml drainage bottle with drain line.This is a poor substitution for a glass evacuated bottle.Their replacement item foams and the suction is less, causing a second needle stick to finish this procedure.Staff were not able to obtain the appropriate amount of blood from the patient, causing potential harm to the patient.What was the original intended procedure? therapeutic phlebotomies (blood letting).Device usage problem: device malfunction - that is, the device did.
 
Manufacturer Narrative
Actual device not evaluated.Unable to properly investigate since the sample was not returned and lot number was not provided.
 
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Brand Name
ASEPT 1,000ML DRAINAGE BOTTLE
Type of Device
BOTTLE COLLECTION, VACUUM
Manufacturer (Section D)
PFM MEDICAL, INC
carlsbad CA
Manufacturer Contact
1815 aston ave.
suite 106
carlsbad, CA 92008
7607588749
MDR Report Key3720842
MDR Text Key4338940
Report Number2032582-2014-00001
Device Sequence Number1
Product Code KDQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/10/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberM7050
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/11/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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