MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-05-20 for PREPIERCED MALE ADAPTER PLUG 11301 manufactured by Hospira De Costa Rica Ltd..
[19029904]
The customer indicated that the device was discarded.
Patient Sequence No: 1, Text Type: N, H10
[19052205]
The customer contact reported a leak of an unspecified radioisotope. The prepierced male adapter plug was attached to the female end of an extension tubing set. The extension tubing set was connected to an unspecified iv catheter. The customer contact reported that an unspecified radioisotope was being delivered iv push through either a 23 gauge or 20 gauge needle into the reseal of the prepierced male adapter plug. It was reported that during delivery, an unspecified amount of radioisotope leaked onto the pt's clothing from the reseal of the prepierced male adapter plug where the reseal had been previously accessed. The pt changed clothing and was scanned with a meter and no radioisotope was noted. The prepierced male adapter plug was replaced and the procedure was completed. There were no reported adverse pt effects. No medical interventions were reported. Though requested, no add'l info was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615050-2008-00140 |
| MDR Report Key | 1048399 |
| Report Source | 05 |
| Date Received | 2008-05-20 |
| Date of Report | 2008-04-22 |
| Date of Event | 2008-04-01 |
| Date Mfgr Received | 2008-04-22 |
| Date Added to Maude | 2008-10-16 |
| 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 WEST 102ND ST DEPT #097U, BLDG #HW1, # 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 | 2008-05-20 |
| Model Number | NA |
| Catalog Number | 11301 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1048265 |
| Manufacturer | HOSPIRA DE COSTA RICA LTD. |
| Manufacturer Address | ZONA FRANCA GLOBAL LA AURORA DE HEREDIA CS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-05-20 |