MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-19 for PPCLRVUE ISP 8FPU SIOM 5608062 manufactured by Bard Access Systems.
[184288050]
Manufacturing review: as the lot number for the device was provided, a manufacturing review was not required to be performed. Labeling review: a review of product labeling documents (e. G. , procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate. Investigation summary: a sample evaluation could not be performed as the samples were not returned therefore the investigation is inconclusive for the alleged port incision redness and tiny hole "not healing" issue due to the fact that no sample was returned for evaluation. Although a definitive root cause could not be determined, the following contributing factor improper placement technique could have potentially caused or contributed to the reported event. (expiration date: 02/2021).
Patient Sequence No: 1, Text Type: N, H10
[184288051]
It was reported that some time post port device implant, the patient experienced redness and presence of a hole at the incision site. Reportedly, the patient was recommended to seek assessment of the incision site by an emergency room physician. The patient status is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2020-00891 |
| MDR Report Key | 9856394 |
| Report Source | CONSUMER |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date Mfgr Received | 2020-02-25 |
| Date Added to Maude | 2020-03-19 |
| 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 | JUDITH LUDWIG |
| Manufacturer Street | 1415 W. 3RD STREET |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal | 85281 |
| Manufacturer Phone | 4803032689 |
| Manufacturer G1 | BARD REYNOSA S.A. DE C.V. |
| Manufacturer Street | BLVD MONTEBELLO #1 PARQUE INDUSTRIAL COLONIAL |
| Manufacturer City | REYNOSA TAMAULIPAS 88780 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88780 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PPCLRVUE ISP 8FPU SIOM |
| Generic Name | IMPLANTABLE PORT |
| Product Code | LJT |
| Date Received | 2020-03-19 |
| Model Number | 5608062 |
| Catalog Number | 5608062 |
| Lot Number | REDW1451 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD ACCESS SYSTEMS |
| Manufacturer Address | 605 N. 5600 W. SALT LAKE CITY UT 84116 US 84116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-19 |