SUREPATH PRESERVATIVE COLLECTION

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-22 for SUREPATH PRESERVATIVE COLLECTION manufactured by Bd Canada.

Event Text Entries

[53439678] (b)(4) alert id: (b)(4): mfr: bd (b)(6) description: surepath preservative collection vial and vial cap. Reason: it has been confirmed that a portion of bd surepath collection vials associated with specific production lots may contain caps that are cracked, which can lead to leaking of the preservative fluid. Bd recommends that you check current unused inventory prior to use, identify affected vials and discard per standard lab practices. Bd will issue replacement for the discarded material.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report NumberMW5064324
MDR Report Key5903535
Date Received2016-08-22
Date of Report2016-08-22
Date of Event2016-08-15
Date Added to Maude2016-08-25
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 1

Brand NameSUREPATH PRESERVATIVE COLLECTION
Generic NameSUREPATH PRESERVATIVE COLLECTION
Product CodeMAQ
Date Received2016-08-22
Lot Number5245805
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerBD CANADA

Device Sequence Number: 2

Brand NameSUREPATH PRESERVATIVE COLLECTION
Generic NameSUREPATH PRESERVATIVE COLLECTION
Product CodeMAQ
Date Received2016-08-22
Lot Number5245805
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No2
Device Event Key0
ManufacturerBD CANADA

Device Sequence Number: 3

Brand NameSUREPATH PRESERVATIVE COLLECTION
Generic NameSUREPATH PRESERVATIVE COLLECTION
Product CodeMAQ
Date Received2016-08-22
Lot Number5245805
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No3
Device Event Key0
ManufacturerBD CANADA

Device Sequence Number: 4

Brand NameSUREPATH PRESERVATIVE COLLECTION
Generic NameSUREPATH PRESERVATIVE COLLECTION
Product CodeMAQ
Date Received2016-08-22
Lot Number5245805
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No4
Device Event Key0
ManufacturerBD CANADA

Device Sequence Number: 5

Brand NameSUREPATH PRESERVATIVE COLLECTION
Generic NameSUREPATH PRESERVATIVE COLLECTION
Product CodeMAQ
Date Received2016-08-22
Lot Number5245805
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No5
Device Event Key0
ManufacturerBD CANADA

Device Sequence Number: 6

Brand NameSUREPATH PRESERVATIVE COLLECTION
Generic NameSUREPATH PRESERVATIVE COLLECTION
Product CodeMAQ
Date Received2016-08-22
Lot Number5245805
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No6
Device Event Key0
ManufacturerBD CANADA

Device Sequence Number: 7

Brand NameSUREPATH PRESERVATIVE COLLECTION
Generic NameSUREPATH PRESERVATIVE COLLECTION
Product CodeMAQ
Date Received2016-08-22
Lot Number5245805
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No7
Device Event Key0
ManufacturerBD CANADA

Device Sequence Number: 8

Brand NameSUREPATH PRESERVATIVE COLLECTION
Generic NameSUREPATH PRESERVATIVE COLLECTION
Product CodeMAQ
Date Received2016-08-22
Lot Number5245805
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No8
Device Event Key0
ManufacturerBD CANADA

Device Sequence Number: 9

Brand NameSUREPATH PRESERVATIVE COLLECTION
Generic NameSUREPATH PRESERVATIVE COLLECTION
Product CodeMAQ
Date Received2016-08-22
Lot Number5245805
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No9
Device Event Key0
ManufacturerBD CANADA

Device Sequence Number: 10

Brand NameSUREPATH PRESERVATIVE COLLECTION
Generic NameSUREPATH PRESERVATIVE COLLECTION
Product CodeMAQ
Date Received2016-08-22
Lot Number5245805
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No10
Device Event Key0
ManufacturerBD CANADA

Device Sequence Number: 11

Brand NameSUREPATH PRESERVATIVE COLLECTION
Generic NameSUREPATH PRESERVATIVE COLLECTION
Product CodeMAQ
Date Received2016-08-22
Lot Number5245805
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No11
Device Event Key0
ManufacturerBD CANADA

Device Sequence Number: 12

Brand NameSUREPATH PRESERVATIVE COLLECTION
Generic NameSUREPATH PRESERVATIVE COLLECTION
Product CodeMAQ
Date Received2016-08-22
Lot Number5245805
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No12
Device Event Key0
ManufacturerBD CANADA

Device Sequence Number: 13

Brand NameSUREPATH PRESERVATIVE COLLECTION
Generic NameSUREPATH PRESERVATIVE COLLECTION
Product CodeMAQ
Date Received2016-08-22
Lot Number5245805
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No13
Device Event Key0
ManufacturerBD CANADA

Device Sequence Number: 14

Brand NameSUREPATH PRESERVATIVE COLLECTION
Generic NameSUREPATH PRESERVATIVE COLLECTION
Product CodeMAQ
Date Received2016-08-22
Lot Number5245805
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No14
Device Event Key0
ManufacturerBD CANADA

Device Sequence Number: 15

Brand NameSUREPATH PRESERVATIVE COLLECTION
Generic NameSUREPATH PRESERVATIVE COLLECTION
Product CodeMAQ
Date Received2016-08-22
Lot Number5245805
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No15
Device Event Key0
ManufacturerBD CANADA

Patients

Patient NumberTreatmentOutcomeDate
10 2016-08-22
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