MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-13 for ASPIRA PERITONEAL DRAINAGE UNKNOWN manufactured by Bard Access Systems.
[89969514]
The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. The device has not been returned to the manufacturer for evaluation, as the device remains in the patient. A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant. Sample remains in patient.
Patient Sequence No: 1, Text Type: N, H10
[89969515]
It was reported that the home care nurse was attempting to drain an aspira peritoneal patient on (b)(6) 2017. The nurse stated this was the first attempt at drainage since catheter placement on (b)(6) 2017. The nurse stated she had tried two drainage kits and noted very little drainage, even though the patient was distended and uncomfortable. She also noted there was leakage coming from the insertion and exit sites of the catheter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2017-01837 |
| MDR Report Key | 6949746 |
| Date Received | 2017-10-13 |
| Date of Report | 2017-10-13 |
| Date of Event | 2017-09-24 |
| Date Added to Maude | 2017-10-13 |
| 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 | SHELLY GILBERT |
| Manufacturer Street | 605 N. 5600 W. |
| Manufacturer City | SALT LAKE CITY UT 84116 |
| Manufacturer Country | US |
| Manufacturer Postal | 84116 |
| Manufacturer Phone | 8015225640 |
| Manufacturer G1 | BARD REYNOSA S.A. DE C.V. -9617592 |
| Manufacturer Street | BLVD. MONTEBELLO #1 PARQUE INDUSTRIAL COLONIAL |
| Manufacturer City | REYNOSA, TAMAULIPAS |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ASPIRA PERITONEAL DRAINAGE |
| Generic Name | PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING |
| Product Code | PNG |
| Date Received | 2017-10-13 |
| Catalog Number | UNKNOWN |
| Lot Number | UNK |
| 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 | 2017-10-13 |