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..
[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
| Report Number | 8030665-2020-00379 |
| MDR Report Key | 9908862 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-04-01 |
| Date of Event | 2020-03-14 |
| Date Mfgr Received | 2020-03-16 |
| Device Manufacturer Date | 2019-08-24 |
| Date Added to Maude | 2020-03-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MATTHEW AMARAL |
| Manufacturer Street | 920 WINTER ST |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 7816999758 |
| Manufacturer G1 | ERIKA DE REYNOSA, S.A. DE C.V. |
| Manufacturer Street | DIRECTOR, QUALITY SYSTEMS 1100 E, MILITARY HWY, SUITE C |
| Manufacturer City | PHARR TX 78577 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78577 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAFE LOCK APD LUER LOCK CONNECTOR |
| Generic Name | SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE |
| Product Code | KDJ |
| Date Received | 2020-03-31 |
| Model Number | 050-95018 |
| Catalog Number | 050-95018 |
| Lot Number | 19KR08215 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ERIKA DE REYNOSA, S.A. DE C.V. |
| Manufacturer Address | MIKE ALLEN #1331 PARQUE INDUSTRIAL REYNOSA REYNOSA 88780 MX 88780 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |