MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-13 for INSUFFLATION NEEDLE PN150 manufactured by Ethicon Endo-surgery, Llc..
[45211928]
(b)(4). Date sent: 5/13/2016. Pt info; relevant tests/lab data, other relevant history; concomitant medical products: information was not provided by the initial contact. Model and lot #; evaluation info: information is unavailable. Attempts have been made to retrieve the device. To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent. The lot history records were reviewed and the manufacturing criteria were met prior to the release of this lot.
Patient Sequence No: 1, Text Type: N, H10
[45211929]
It was reported that prior to an unknown procedure, "num renal unit stated that needle does not retract as stated in ifu. Product used to insert renal dialysis catheters. " it is unknown how the procedure was completed. There were no adverse consequences for the patient reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005075853-2016-02711 |
| MDR Report Key | 5653421 |
| Date Received | 2016-05-13 |
| Date of Report | 2016-04-20 |
| Date of Event | 2016-04-20 |
| Date Mfgr Received | 2016-04-20 |
| Device Manufacturer Date | 2015-08-05 |
| Date Added to Maude | 2016-05-13 |
| 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 | MILTON GARRETT |
| Manufacturer Street | 4545 CREEK ROAD ML 120A |
| Manufacturer City | CINCINNATI OH 45242 |
| Manufacturer Country | US |
| Manufacturer Postal | 45242 |
| Manufacturer Phone | 5133378865 |
| Manufacturer G1 | ETHICON ENDO-SURGERY, LLC |
| Manufacturer Street | 475 CALLE C |
| Manufacturer City | GUAYNABO PR 00969 |
| Manufacturer Postal Code | 00969 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | INSUFFLATION NEEDLE |
| Generic Name | INSUFFLATION NEEDLE |
| Product Code | FDP |
| Date Received | 2016-05-13 |
| Model Number | NA |
| Catalog Number | PN150 |
| Lot Number | M4HX0T |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON ENDO-SURGERY, LLC. |
| Manufacturer Address | 475 CALLE C GUAYNABO PR 00969 00969 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-13 |