PENCAN N/A 4502027-01

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 2018-10-11 for PENCAN N/A 4502027-01 manufactured by B. Braun Melsungen Ag.

Event Text Entries

[124677775] (b)(4). This report has been identified as event two of b. Braun (b)(4) internal report # (b)(4). No sample has been returned for investigation. If the sample and/or additional pertinent information becomes available, a follow up report will be submitted. Retention sample: pencan 27gx3 1/2 (0. 4x88mm)-eu, mat no. 4502027-01xx, batch no. 18c01h8b23. Functional test: stiffness test, spec: max 0. 65mm, retention sample: 0. 346mm, span: 7. 5mm, weight: 5. 5n. Result: pass. A review of the batch and manufacturing records revealed no abnormalities or nonconformities.
Patient Sequence No: 1, Text Type: N, H10


[124677776] As reported by the user facility (translation of user facility information by bbm sales organization in (b)(6): event 2. Pencan broken inside patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610825-2018-00218
MDR Report Key7957094
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2018-10-11
Date of Report2019-01-03
Date of Event2018-09-10
Date Facility Aware2018-10-09
Report Date2019-01-03
Date Reported to FDA2019-01-03
Date Reported to Mfgr2019-01-03
Date Mfgr Received2018-09-17
Device Manufacturer Date2018-03-01
Date Added to Maude2018-10-11
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 NamePENCAN
Generic NameSPINAL NEEDLE
Product CodeMIA
Date Received2018-10-11
Returned To Mfg2018-10-18
Model NumberN/A
Catalog Number4502027-01
Lot Number18C01H8B23
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Age6 MO
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerB. BRAUN MELSUNGEN AG
Manufacturer AddressCARL-BRAUN-STR. 1 MELSUNGEN, HESSEN 34212 GM 34212


Patients

Patient NumberTreatmentOutcomeDate
10 2018-10-11

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