MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-30 for ARROWGARD BLUE PLUS PRESSURE INJECTABLE TRIPLE LUMEN CVC KIT CDC-45703-P1A manufactured by Teleflex Medical.
[185517607]
As the nurse was changing the dressing to their patient's right ij triple lumen, they noted blood to be pouring from the line. As the nurse looked closer, they noted that the blood was coming from the proximal port line and there happened to be a small "nick" on the tubing. The tubing was immediately clamped and line was removed and saved and the unit nurse manager was made aware of the event by the bedside nurse. The nurse manager and nurse looked at and examined the line together. The nurse reported they did not use anything invasive that would cause damage to line (i. E. No scissors utilized). No change in practice or process necessary. The patient did not have any adverse effects because of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9897084 |
| MDR Report Key | 9897084 |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-03-09 |
| Report Date | 2020-03-25 |
| Date Reported to FDA | 2020-03-25 |
| Date Reported to Mfgr | 2020-03-30 |
| Date Added to Maude | 2020-03-30 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARROWGARD BLUE PLUS PRESSURE INJECTABLE TRIPLE LUMEN CVC KIT |
| Generic Name | CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS |
| Product Code | FOZ |
| Date Received | 2020-03-30 |
| Catalog Number | CDC-45703-P1A |
| Lot Number | 13G19G0677 |
| Device Availability | * |
| Device Age | 9 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | 3015 CARRINGTON MILL BLVD. MORRISVILLE NC 27560 US 27560 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |