STATLOCK PICC PLUS SLIDING POST, CRESCENT PAD, INCLUDES SKIN PREP N/A VPPCSPCE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-17 for STATLOCK PICC PLUS SLIDING POST, CRESCENT PAD, INCLUDES SKIN PREP N/A VPPCSPCE manufactured by Bard Access Systems.

Event Text Entries

[142348678] The information provided by bd represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd. The device has not been returned, at this time, to the manufacturer for evaluation. A lot history review (lhr) of juctf145 showed no other similar product complaint(s) from this lot number. Device not yet returned.
Patient Sequence No: 1, Text Type: N, H10


[142348679] It was reported "damaged statlock. The fixation from the stabilization device to the catheter was desprended. All samples analyzed from the same batch have this issue. The patient lost cvc due to this incident. "
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3006260740-2019-00909
MDR Report Key8525081
Date Received2019-04-17
Date of Report2019-07-16
Date of Event2019-03-25
Date Mfgr Received2019-07-10
Device Manufacturer Date2018-06-01
Date Added to Maude2019-04-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKELSEY ERICKSON
Manufacturer Street605 N. 5600 W.
Manufacturer CitySALT LAKE CITY UT 84116
Manufacturer CountryUS
Manufacturer Postal84116
Manufacturer Phone8015225937
Manufacturer G1DAVOL SURGICAL INNOVATIONS -9616067
Manufacturer StreetAVE. ROBERTO FIERRO #6408 PARQUE INDUSTRIAL AEROPUERTO
Manufacturer CityCD. JUAREZ, CHIH S.A. DE C.V. 32690
Manufacturer CountryMX
Manufacturer Postal Code32690
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameSTATLOCK PICC PLUS SLIDING POST, CRESCENT PAD, INCLUDES SKIN PREP
Generic NameSTAND, INFUSION
Product CodeFOX
Date Received2019-04-17
Returned To Mfg2019-05-22
Model NumberN/A
Catalog NumberVPPCSPCE
Lot NumberJUCTF145
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBARD ACCESS SYSTEMS
Manufacturer Address605 N. 5600 W. SALT LAKE CITY UT 84116 US 84116


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-17

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