MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2010-11-18 for INSUFFLATION NEEDLE - PN120 manufactured by Ethicon Endo-surgery, Llc..
[1758245]
It was reported that during a laparoscopic procedure, air could not be entered after puncture. Another device was used to complete the procedure. There were no adverse consequences for the patient.
Patient Sequence No: 1, Text Type: D, B5
[1801261]
The customer stated that he checked his insulin and he had 21units in the reservoir. An hour later, he received a no delivery alarm during basal, and when he checked his status screen, it was 0 units left in the reservoir. The customer stated that similar incidents happened two to three times in the past two weeks. Troubleshooting was performed. The alarm history revealed a motor error alarm. Ran a displacement test and self test and the device passed the tests. Requested the customer to reviewed the amount of insulin in the reservoir prior inserting in the device. Asked the customer to check the units left on status screen to see if the totals matched. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
[8904713]
(b)(4). After several requests, the device was not received for analysis.
Patient Sequence No: 1, Text Type: N, H10
[8976621]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005075853-2010-06590 |
| MDR Report Key | 1902603 |
| Report Source | * |
| Date Received | 2010-11-18 |
| Date of Report | 2010-10-27 |
| Date of Event | 2010-10-26 |
| Date Mfgr Received | 2010-12-02 |
| Date Added to Maude | 2010-12-02 |
| 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 | 0 |
| Manufacturer Contact | KATHY RICE |
| Manufacturer Street | 4545 CREEK RD |
| Manufacturer City | CINCINNATI OH 452422803 |
| Manufacturer Country | US |
| Manufacturer Postal | 452422803 |
| Manufacturer Phone | 5133373299 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INSUFFLATION NEEDLE - |
| Generic Name | INSUFFLATION NEEDLE - 120MM LENGTH |
| Product Code | FDP |
| Date Received | 2010-11-18 |
| Catalog Number | PN120 |
| Lot Number | UNK |
| ID Number | BATCH UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2010-11-18 |