MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-20 for ASPIRA PERITONEAL DRAINAGE KIT 1L N/A 4992207 manufactured by Bard Access Systems.
[87885812]
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) of rebt2301 showed no other similar product complaint(s) from this lot number.
Patient Sequence No: 1, Text Type: N, H10
[87885813]
Per ms and s, the hospice nurse called to report drainage issues with a patient's aspira catheter. After placement, he drained ~1,000 cc. During the last two drainage sessions, he drained ~ 600 cc each time. Today, he only drained ~ 10 cc. He experiences shortness of breath even when he has been able to drain, but his shortness of breath is worse since he isn't getting much fluid out. They tried 2 drainage kits, but the bulb did not expand after squeezing it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2017-01654 |
| MDR Report Key | 6880290 |
| Date Received | 2017-09-20 |
| Date of Report | 2017-09-20 |
| Device Manufacturer Date | 2017-06-01 |
| Date Added to Maude | 2017-09-20 |
| 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 | KELSEY ERICKSON |
| Manufacturer Street | 605 N. 5600 W. |
| Manufacturer City | SALT LAKE CITY UT 84116 |
| Manufacturer Country | US |
| Manufacturer Postal | 84116 |
| Manufacturer Phone | 8015225937 |
| 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 KIT 1L |
| Generic Name | PERITONEAL DIALYSIS SYSTEM AND ACCESSORIES |
| Product Code | PNG |
| Date Received | 2017-09-20 |
| Model Number | N/A |
| Catalog Number | 4992207 |
| Lot Number | REBT2301 |
| 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 | 2017-09-20 |