MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-03-21 for FOLEY CATHETER WITH TEMPERATURE SENSOR BS81-080414 manufactured by Deroyal Cientifica De Latinoamerica S.r.l..
[139573515]
Investigation summary: an internal complaint (b)(4) was received reporting that a foley catheter (part bs81-080414, lot 48279557) had a blockage in the inner lumen, which resulted in no urine drainage. This caused a urinary catheterization failure on the operating patient. It was reported that the patient was not injured. Initially, the defective sample was reported to be available for return. However, no sample was returned. Photos of the defective sample were provided instead. The investigation is ongoing at this time. When new and critical information is received, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[139573516]
A blockage was found in the inner lumen of a foley catheter, which resulted in no urine drainage. This caused urine catherization failure on an operating patient. The patient was not injured. The catheter balloon tested ok.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320762-2019-00001 |
| MDR Report Key | 8439529 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-03-21 |
| Date of Report | 2019-05-03 |
| Date of Event | 2019-02-19 |
| Date Mfgr Received | 2019-02-19 |
| Date Added to Maude | 2019-03-21 |
| 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 | SARAH BENNETT |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653626112 |
| Manufacturer G1 | DEROYAL INDUSTRIES, INC. |
| Manufacturer Street | 1595 HIGHWAY 33 SOUTH |
| Manufacturer City | NEW TAZEWELL TN 37825 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37825 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FOLEY CATHETER WITH TEMPERATURE SENSOR |
| Generic Name | CATHETER, UPPER URINARY TRACT |
| Product Code | EYC |
| Date Received | 2019-03-21 |
| Model Number | BS81-080414 |
| Lot Number | 48279557 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L. |
| Manufacturer Address | GLOBAL PARK, BOX 180-3006 602 PARKWAY, LA AURORA HEREDIA, HEREDIA 146 CS 146 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-21 |