MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-12-22 for PREPIERCED MALE ADAPTER PLUG 11301 manufactured by Hospira De Costa Rica Ltd..
[18242657]
The customer contact reported blood loss. It was reported that after connecting the male adapter plug to the patient's catheter, blood leaked from the connection. The amount of blood loss was reported as minimal. The male adapter plug was replaced and the therapy was initiated. There were no reported adverse patient effects. No medical interventions were reported. Though requested, no additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
[18351009]
The device is expected to be returned for investigation. It has not yet been received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615050-2008-00373 |
| MDR Report Key | 1349008 |
| Report Source | 05 |
| Date Received | 2008-12-22 |
| Date of Report | 2008-12-04 |
| Date of Event | 2008-12-04 |
| Date Mfgr Received | 2008-12-04 |
| Device Manufacturer Date | 2008-07-01 |
| Date Added to Maude | 2009-06-17 |
| 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 | STEVEN COX, DIRECTOR |
| Manufacturer Street | 8401 WEST 102ND ST., SUITE 300 DEPT. NO. 097U, BLDG. NO. HW1 |
| Manufacturer City | PLEASANT PRAIRIE WI 53158 |
| Manufacturer Country | US |
| Manufacturer Postal | 53158 |
| Manufacturer Phone | 2625776072 |
| Manufacturer G1 | HOSPIRA DE COSTA RICA LTD. |
| Manufacturer Street | ZONA FRANCA GLOBAL |
| Manufacturer City | LA AURORA DE HEREDIA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PREPIERCED MALE ADAPTER PLUG |
| Generic Name | 79-GCE |
| Product Code | GCE |
| Date Received | 2008-12-22 |
| Model Number | NA |
| Catalog Number | 11301 |
| Lot Number | 671285H |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOSPIRA DE COSTA RICA LTD. |
| Manufacturer Address | ZONA FRANCA GLOBAL LA AURORA DE HEREDIA CS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-12-22 |