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..
[1064109]
The customer contact reported blood loss. It was reported that after connecting the male adapter plug to the pt's catheter, blood leaked from the connection. It was estimated that the volume of blood loss was no more than 3 ml. The male adapter plug was replaced and the therapy was initiated. There were no reported adverse pt effects. No medical interventions were reported. Though requested, no additional info was provided.
Patient Sequence No: 1, Text Type: D, B5
[8186476]
The customer indicated that the device was discarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615050-2008-00371 |
| MDR Report Key | 1348978 |
| Report Source | 05 |
| Date Received | 2008-12-22 |
| Date of Report | 2008-11-24 |
| Date of Event | 2008-11-24 |
| Date Mfgr Received | 2008-11-24 |
| Device Manufacturer Date | 2008-07-01 |
| Date Added to Maude | 2009-06-19 |
| 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 | STEVEN COX, DIR |
| Manufacturer Street | 8401 W 102ND ST, DEPT NO 097U BLDG NO HW1, STE 300 |
| 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 | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 |