CONTIPLEX? 331641

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-02-18 for CONTIPLEX? 331641 manufactured by B. Braun Medical Inc..

Event Text Entries

[180420010] This report has been identified as b. Braun medical internal report number (b)(4). The device involved has not been received for evaluation and the investigation is ongoing at this time. A follow up will be submitted when the investigation results become available.
Patient Sequence No: 1, Text Type: N, H10


[180420011] As reported by the user facility: description of issue: on (b)(6) 2020, patient received a femoral nerve block. On (b)(6) 2020, the catheter was removed and 1 cm of the blue tip was noted to be missing. It appeared that the tip was sheared off. An x-ray was done and no catheter was seen. No redness, tenderness, swelling was noted at the site. Surgeon was consulted and it was recommended to monitor the site. No additional treatments were performed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2523676-2020-00012
MDR Report Key9720667
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-02-18
Date of Report2020-03-24
Date of Event2020-02-03
Date Mfgr Received2020-02-04
Date Added to Maude2020-02-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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
Manufacturer ContactMR. JONATHAN SEVERINO
Manufacturer Street901 MARCON BLVD.
Manufacturer CityALLENTOWN, PA
Manufacturer CountryUS
Manufacturer Phone7197287
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCONTIPLEX?
Generic NameNERVE BLOCK TRAY (KIT)
Product CodeOGJ
Date Received2020-02-18
Returned To Mfg2020-03-06
Model Number331641
Catalog Number331641
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerB. BRAUN MEDICAL INC.
Manufacturer Address901 MARCON BLVD. ALLENTOWN, PA US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-18

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