RECONSTITUTION ACCESSORIES 7O5993

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-17 for RECONSTITUTION ACCESSORIES 7O5993 manufactured by B. Braun Medical Inc..

Event Text Entries

[48512426] (b)(4). Four (4) unused, unopened samples, in packaging indicating the reported lot # 0061385505, were received for evaluation. Upon visual observation, the paper backing of the blister package was noted to be torn/ripped on all four samples. The tears were all near the middle of the package. Due to this issue, the packaging line for this product was inspected and reviewed. The current box size and packaging configuration was validated and found to be sufficient for this product. There have been no changes to the packaging configuration or blister size since. This blister packed product is shipped to a wholesale medical distribution company, where it is packaged into a kit. Since the reported issue was observed at the end user facility, it could not be definitively determined where in the packaging/shipping/handling process this issue occurred. Although our packaging is tested to astm standards during development to ensure that they will maintain integrity under normal to strenuous shipping conditions, excessive handling may result in some damage. Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature. No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or lot number. If additional pertinent information becomes available a follow-up report will be filed.
Patient Sequence No: 1, Text Type: N, H10


[48512427] As reported by the user facility: event # 2: reports two tice bcg units had tubing packaging that had a hole in the plastic, making the tubing unsterile.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2523676-2016-00370
MDR Report Key5733139
Date Received2016-06-17
Date of Report2015-01-15
Date of Event2014-12-29
Date Mfgr Received2015-01-15
Device Manufacturer Date2014-08-25
Date Added to Maude2016-06-17
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 ContactMR. ROBERT HUBERT
Manufacturer Street901 MARCON BLVD.
Manufacturer CityALLENTOWN PA 18109
Manufacturer CountryUS
Manufacturer Postal18109
Manufacturer Phone6102660500
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameRECONSTITUTION ACCESSORIES
Generic NameRECONSTITUTION ACCESSORIES
Product CodeFPK
Date Received2016-06-17
Returned To Mfg2015-01-27
Catalog Number7O5993
Lot Number0061385505
Device Expiration Date2016-07-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerB. BRAUN MEDICAL INC.
Manufacturer Address901 MARCON BLVD. ALLENTOWN PA 18109 US 18109


Patients

Patient NumberTreatmentOutcomeDate
10 2016-06-17

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