MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-18 for OPTIDRAIN, LOCK PIGTAIL, 8FR X 30 CM NOD8LPT manufactured by Bard Access Systems.
[142622736]
This report summarizes one malfunction event. A review of the event indicated that model nod8lpt drainage device experienced a crack. Of this event, the device was used on the patient with no reported injury. The patient was a (b)(6)-year-old man weighing (b)(6)kgs.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2019-00974 |
| MDR Report Key | 8528531 |
| Date Received | 2019-04-18 |
| Date of Report | 2019-04-18 |
| Date Mfgr Received | 2019-03-31 |
| Date Added to Maude | 2019-04-18 |
| 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 | 1625 W 3RD ST. |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal | 85281 |
| Manufacturer Phone | 4803032689 |
| Manufacturer G1 | C.R. BARD, INC. (GFO) |
| Manufacturer Street | 289 BAY ROAD |
| Manufacturer City | QUEENSBURY NY 12804 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | OPTIDRAIN, LOCK PIGTAIL, 8FR X 30 CM |
| Generic Name | DRAINAGE DEVICE |
| Product Code | DWM |
| Date Received | 2019-04-18 |
| Catalog Number | NOD8LPT |
| Lot Number | GFCR0726 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| 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 | 2019-04-18 |