CENTRAL LINE<34 WEEKS KIT * DYNDC1988A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-05-27 for CENTRAL LINE<34 WEEKS KIT * DYNDC1988A manufactured by Medline Industries Inc..

Event Text Entries

[5909972] We have 2 central line kits that are labeled as the same product, both are labeled "<34 week kit", but the kits have 2 different reference numbers and contain different products. The kit with reference number: (b)(4) kit does not have chg (chlorhexidine gluconate) and the kit with reference number: (b)(4) contains chg (biopatch). Staff could pick a kit and it would contain chg--that should not be used for preemies less than 34 weeks.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number4840103
MDR Report Key4840103
Date Received2015-05-27
Date of Report2015-05-27
Date of Event2015-05-05
Report Date2015-05-27
Date Added to Maude2015-06-12
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameCENTRAL LINE
Generic NameCENTRAL LINE KIT
Product CodeOFF
Date Received2015-05-27
Model Number*
Catalog NumberDYNDC1988A
Lot Number14QB2622
ID Number*
Device AvailabilityY
Device Age1 DA
Device Sequence No1
Device Event Key0
ManufacturerMEDLINE INDUSTRIES INC.
Manufacturer Address1 MEDLINE PLACE MUNDELEIN IL 60060 US 60060

Device Sequence Number: 2

Brand NameCENTRAL LINE
Generic NameCENTRAL LINE KIT
Product CodeOFF
Date Received2015-05-27
Model Number*
Catalog NumberDYN1987A
Lot Number14DB9277
ID Number*
Device AvailabilityY
Device Age1 DA
Device Sequence No2
Device Event Key0
ManufacturerMEDLINE INDUSTRIES INC.
Manufacturer Address1 MEDLINE PLACE MUNDELEIN IL 60060 US 60060

Device Sequence Number: 3

Brand Name*
Generic Name*
Product Code---
Date Received2015-05-27
Device Sequence No3
Device Event Key0
ManufacturerMEDLINE INDUSTRIES INC.
Manufacturer Address1 MEDLINE PLACE MUNDELEIN 60060 60060

Device Sequence Number: 4

Brand Name*
Generic Name*
Product Code---
Date Received2015-05-27
Model Number*
Catalog Number*
Lot Number*
ID Number*
Device Availability*
Device Age*
Device Sequence No4
Device Event Key0
ManufacturerMEDLINE INDUSTRIES INC.
Manufacturer Address1 MEDLINE PLACE MUNDELEIN 60060 * 60060

Patients

Patient NumberTreatmentOutcomeDate
10 2015-05-27
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.