MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-03-14 for HENORA 300PSI I.V. CATHETER EXTENSION SET 70-4026-09V1 manufactured by Rgi Medical Manufacturing Inc..
[4613829]
The catheter extension set had been previously put in place on the patient by emergency room staff at an earlier time. During the night, the patient rang their call bell because they felt part of the bed getting wet by where the iv set was placed. The nurse answered the call and found that catheter extension set had come apart at the connection to the hep lock cap. The nurse estimated that the patient had lost around 250 ml of blood. The patient was not injured and the i. V. Was restarted without incident.
Patient Sequence No: 1, Text Type: D, B5
[11961657]
There have been difficulties communicating with the health care provider about the return of the device. Numerous attempts have been made by telephone and e-mail to contact the health care provided to obtain add'l info and the manufacturer is still attempting to acquire the device for testing. The lot number/date of manufacture was not known because the device packaging had been discarded prior to the device issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004994611-2014-00001 |
| MDR Report Key | 3847046 |
| Report Source | 07 |
| Date Received | 2014-03-14 |
| Date of Report | 2014-02-14 |
| Date of Event | 2014-02-13 |
| Date Mfgr Received | 2014-02-14 |
| Date Added to Maude | 2014-06-19 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JESSE BISHOP |
| Manufacturer Street | 4637 NORTH WEST 6TH STREET |
| Manufacturer City | GAINESVILLE FL 32609 |
| Manufacturer Country | US |
| Manufacturer Postal | 32609 |
| Manufacturer Phone | 3523783633 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HENORA 300PSI I.V. CATHETER EXTENSION SET |
| Generic Name | INTRAVENOUS EXTENSION TUBING SET |
| Product Code | GCD |
| Date Received | 2014-03-14 |
| Model Number | NA |
| Catalog Number | 70-4026-09V1 |
| Lot Number | NOT AVAILABLE |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RGI MEDICAL MANUFACTURING INC. |
| Manufacturer Address | GAINESVILLE FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-03-14 |