MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-06 for ASPIRA PLEURAL/PERITONEAL DRAINAGE KIT 1L 4992209 manufactured by Bard Access Systems.
[104774109]
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 manufacturer has received the sample and will evaluate. Results are expected soon. A lot history review (lhr) of rebv1918 showed no other similar product complaint(s) from this lot number.
Patient Sequence No: 1, Text Type: N, H10
[104774110]
It was reported that the aspira drainage catheter was leaking from the hub. No additional information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2018-00647 |
| MDR Report Key | 7404506 |
| Date Received | 2018-04-06 |
| Date of Report | 2018-06-22 |
| Date Mfgr Received | 2018-03-26 |
| Device Manufacturer Date | 2017-08-01 |
| Date Added to Maude | 2018-04-06 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TESHA UDY |
| Manufacturer Street | 605 N. 5600 W. |
| Manufacturer City | SALT LAKE CITY UT 84116 |
| Manufacturer Country | US |
| Manufacturer Postal | 84116 |
| Manufacturer Phone | 8015225819 |
| 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 PLEURAL/PERITONEAL DRAINAGE KIT 1L |
| Generic Name | PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING |
| Product Code | PNG |
| Date Received | 2018-04-06 |
| Returned To Mfg | 2018-03-26 |
| Model Number | 4992209 |
| Catalog Number | 4992209 |
| Lot Number | REBV1918 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-04-06 |