MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-24 for SAFE LOCK APD LUER LOCK CONNECTOR 050-95018 manufactured by Erika De Reynosa, S.a. De C.v..
[184852427]
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
Patient Sequence No: 1, Text Type: N, H10
[184852428]
It was reported that a peritoneal dialysis (pd) patient discovered a fluid leak during their pd treatment. The patient reported receiving an air detected in cassette alarm during dwell 4 of 5 of treatment. The fluid did not come into contact with the cycler. It is unknown at which point in therapy the leak may have begun. The cause of the leak is unknown. The patient was advised to reset up with new supplies and follow up with their peritoneal dialysis nurse (pdrn). Upon follow up, the patient contact stated that per the clinic? S procedure the patient was prescribed prophylactic antibiotics, cefphalexin (250 mg, oral, 3 times a day, 3 days). Despite the prophylactic antibiotics, there were no symptoms, adverse events, or injuries requiring medical intervention required as a result of the reported event. The patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed, however stated the patient skipped peritoneal dialysis treatment. The patient contact confirmed that the leaking between the adapter and baxter bag. The adapter used by the patient was available for return for physical evaluation by the manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030665-2020-00353 |
| MDR Report Key | 9872201 |
| Report Source | CONSUMER |
| Date Received | 2020-03-24 |
| Date of Report | 2020-04-02 |
| Date of Event | 2020-03-19 |
| Date Mfgr Received | 2020-04-01 |
| Device Manufacturer Date | 2019-08-29 |
| Date Added to Maude | 2020-03-24 |
| 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 | 2020-03-24 |
| Model Number | 050-95018 |
| Catalog Number | 050-95018 |
| Lot Number | 19KR08214 |
| 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 | 2020-03-24 |