MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-10-15 for PREPIERCED MALE ADAPTER PLUG 11301 manufactured by Hospira Holdings De Costa Rica Ltd..
[682747]
General report received of an unspecified number of undocumented incidents of leaks of radioactive agents. It was reported that this happened when manual injections of contrast were performed using a syringe with an attached needle of unspecified gauge that was inserted into a prepierced male adapter plug, which then was connected to a clave y-site. The customer contact stated that per staff, visible traces of contrast were noted when scanning rooms at the end of the day. There were no reported adverse effects to the patients or staff. Though requested, no additional information provided.
Patient Sequence No: 1, Text Type: D, B5
[8130771]
The actual device involvedc in the reported incident was not returned for analysis. The lot number for this product was not identified; therefore, a review of the batch records could not be performed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615050-2004-00131 |
| MDR Report Key | 904811 |
| Report Source | 05 |
| Date Received | 2004-10-15 |
| Date of Report | 2004-09-20 |
| Date of Event | 2004-09-01 |
| Date Mfgr Received | 2004-09-20 |
| Date Added to Maude | 2007-08-30 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | PAUL LANDESMAN, PH.D ASST. DIR |
| Manufacturer Street | 8401 WEST 102ND STREET STE 300 DEPT.NO097U, BLDG.NO HW1, |
| Manufacturer City | PLEASANT PRAIRIE WI 53138 |
| Manufacturer Country | US |
| Manufacturer Postal | 53138 |
| 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 | CATHETER |
| Product Code | GCE |
| Date Received | 2004-10-15 |
| Model Number | NA |
| Catalog Number | 11301 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 879641 |
| Manufacturer | HOSPIRA HOLDINGS DE COSTA RICA LTD. |
| Manufacturer Address | ZONA FRANCA GLOBAL LA AURORA DE HEREDIA CS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-10-15 |