MEDLINE DYNDBARD8

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-07-25 for MEDLINE DYNDBARD8 manufactured by Medline Industries, Inc..

Event Text Entries

[4896025] During an intravenous (iv) catheter insertion procedure the clinician noted that the catheter was leaking back into the dressing after applying the clear cover dressing. The clinician noted blood seepage in between the slip luer fittings of the catheter and the iv start kit's 6 inch extension set. The clinician attempted to seat the mating sections but the threads would not mesh and the connection felt loose. The clinician exchanged both iv line and extension set and the iv placed without further incident. There have been prior and subsequent failures on this iv catheter and iv start kit. The user has been replacing the iv start kit's extension set with an alternate manufacturer and the iv catheter mates with no leaks or cross threading. However, the infusion center nursing later complained that the iv start kit's themselves were now leaking no matter which extension set was being used. The reported catheter and extension set have been sent to biomed for reporting to the manufacturer for analysis. At this time the infusion center staff is monitoring all iv catheter and extension set connections and assembly process as well as follow up with the manufacturer's involved. The staff is understandably concerned and nervy right now on these issues. This has happened at least 8 times in this department in the last 4 weeks. These are seasoned infusion care nurses so this whole event is out of character for them. Some of the common nursing complaints is that the threaded sections feel as if they are not meshing correctly or if they so twist together correctly they feel loose.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number4071884
MDR Report Key4071884
Date Received2014-07-25
Date of Report2014-07-25
Date of Event2014-07-16
Report Date2014-07-25
Date Reported to FDA2014-07-25
Date Reported to Mfgr2014-09-09
Date Added to Maude2014-09-09
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
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 NameMEDLINE
Generic NameIV START KIT
Product CodeLRS
Date Received2014-07-25
Model NumberDYNDBARD8
Catalog NumberDYNDBARD8
Lot Number14DB5915
ID Number*
OperatorNURSE
Device AvailabilityN
Device Age1 DA
Device Sequence No1
Device Event Key0
ManufacturerMEDLINE INDUSTRIES, INC.
Manufacturer AddressONE MEDLINE PL MUNDELEIN IL 60060 US 60060

Device Sequence Number: 2

Brand NameINSYTE AUTOGUARD
Generic NameIV CATHETER
Product CodeFOZ
Date Received2014-07-25
Model Number*
Catalog Number381412
Lot Number4078780
ID Number*
Device AvailabilityN
Device Age1 DA
Device Sequence No2
Device Event Key0
ManufacturerBECTON DICKINSON INFUSION THERAPY SYSTEM
Manufacturer Address9450 SOUTH STATE ST. SANDY UT 84070 US 84070


Patients

Patient NumberTreatmentOutcomeDate
10 2014-07-25

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