SAFE LOCK APD LUER LOCK CONNECTOR 050-95018

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for SAFE LOCK APD LUER LOCK CONNECTOR 050-95018 manufactured by Erika De Reynosa, S.a. De C.v..

Event Text Entries

[185969058] Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed. A batch records review was conducted by the manufacturer for the reported lot. There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event. The entire lot has been sold and distributed. In addition, a device history review was performed and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements. The lot met all specifications for release. A product history review did not reveal a probable cause for the customer complaint. As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.
Patient Sequence No: 1, Text Type: N, H10


[185969059] It was reported that a peritoneal dialysis (pd) patient encountered a fluid leak from the connection of the adapter to the solution bag during an unknown phase after drain 0 of pd treatment. It is unknown at which point in therapy the leak may have begun. There was no fluid leak observed within the cycler. The patient was advised by the peritoneal dialysis registered nurse (pdrn) to re-setup supplies. Upon follow up, the pdrn is unsure what caused the fluid leak. The patient was able to resolve the issue by further tightening the connection, however, the pdrn advised the patient to re-setup supplies. The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event. The cassette used by the patient was discarded and is not available to return for physical evaluation by the manufacturer.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8030665-2020-00379
MDR Report Key9908862
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2020-04-01
Date of Event2020-03-14
Date Mfgr Received2020-03-16
Device Manufacturer Date2019-08-24
Date Added to Maude2020-03-31
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 ContactMATTHEW AMARAL
Manufacturer Street920 WINTER ST
Manufacturer CityWALTHAM MA 02451
Manufacturer CountryUS
Manufacturer Postal02451
Manufacturer Phone7816999758
Manufacturer G1ERIKA DE REYNOSA, S.A. DE C.V.
Manufacturer StreetDIRECTOR, QUALITY SYSTEMS 1100 E, MILITARY HWY, SUITE C
Manufacturer CityPHARR TX 78577
Manufacturer CountryUS
Manufacturer Postal Code78577
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSAFE LOCK APD LUER LOCK CONNECTOR
Generic NameSET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
Product CodeKDJ
Date Received2020-03-31
Model Number050-95018
Catalog Number050-95018
Lot Number19KR08215
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeMO
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerERIKA DE REYNOSA, S.A. DE C.V.
Manufacturer AddressMIKE ALLEN #1331 PARQUE INDUSTRIAL REYNOSA REYNOSA 88780 MX 88780


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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