PENCAN? 4502124

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 2020-02-14 for PENCAN? 4502124 manufactured by B. Braun Melsungen Ag.

Event Text Entries

[183158831] This report has been identified as b. Braun melsungen (b)(4) internal report # (b)(4). Sample evaluation: received 1 piece of pencan 27gx4" (0. 42x103 mm) w. Guide in opened packaging together with a peel paper with batch no. 16m25g8216. Upon visual inspection, the pencan cannula was broken off. No abnormalities observed on the mandrin and the guide needle. Bmi device history record (dhr): reviewed the dhr for the batch no. 16m25g8216, no abnormalities observed during the in-process and final control inspection. Bmi root cause analysis: pencan product was assembled at bbaj and bmi performed packaging as a finished goods. According to sop, operator manually load pencan needle into the blister. Pencan needle was capped with protective cap and will be sealed and packed into duplex box and then into carton box. There was no direct contact between operator and the cannula during loading process. As pencan is manufactured by b. Braun aesculap (b)(4), this complaint was forwarded to bbaj for further investigation. Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b. Braun medical, inc.
Patient Sequence No: 1, Text Type: N, H10


[183158832] As reported by the user facility (translation of user facility information by bbm sales organization in (b)(6)): broken needle. The broken piece had to be removed by a surgeon.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610825-2020-00028
MDR Report Key9713069
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2020-02-14
Date of Report2020-02-14
Date Mfgr Received2020-01-20
Device Manufacturer Date2016-11-25
Date Added to Maude2020-02-14
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,
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePENCAN?
Generic NameNEEDLE, CONDUCTION, ANESTH
Product CodeBSP
Date Received2020-02-14
Returned To Mfg2020-01-28
Catalog Number4502124
Lot Number16M25G8216
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerB. BRAUN MELSUNGEN AG
Manufacturer AddressCARL-BRAUN-STR. 1 MELSUNGEN,


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-02-14

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