INTROCAN? SAFETY N/A 4253566-01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-04-15 for INTROCAN? SAFETY N/A 4253566-01 manufactured by B. Braun Melsungen Ag.

Event Text Entries

[142037317] (b)(4). No sample has been returned for investigation. The batch record could not be reviewed since the lot number is not known. Without the actual sample or lot number, a thorough investigation can not be performed. All available information has been forwarded to the actual manufacturer. If the sample or lot number and/or additional pertinent information becomes available, a follow up report will be filed.
Patient Sequence No: 1, Text Type: N, H10


[142037318] As reported by the user facility (translation of user facility information by bbm sales organization in (b)(6): catheter-infection.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610825-2019-00115
MDR Report Key8516315
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2019-04-15
Date of Report2019-07-03
Date of Event2019-03-19
Date Facility Aware2019-04-15
Report Date2019-07-03
Date Reported to FDA2019-07-03
Date Reported to Mfgr2019-07-03
Date Mfgr Received2019-03-22
Date Added to Maude2019-04-15
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 Street861 MARCON BLVD.
Manufacturer CityALLENTOWN PA 18109
Manufacturer CountryUS
Manufacturer Postal18109
Manufacturer Phone4842408332
Manufacturer G1B. BRAUN MELSUNGEN AG
Manufacturer StreetCARL-BRAUN-STR. 1
Manufacturer CityMELSUNGEN, 34212
Manufacturer CountryGM
Manufacturer Postal Code34212
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINTROCAN? SAFETY
Generic NameI.V. SAFETY CATHETER
Product CodeDQR
Date Received2019-04-15
Model NumberN/A
Catalog Number4253566-01
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerB. BRAUN MELSUNGEN AG
Manufacturer AddressCARL-BRAUN-STR. 1 MELSUNGEN, HESSEN 34212 GM 34212


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-15

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