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..
[702067]
Report 2 of 2 received a lack of radioactive agent. On thursday (date unknown), a prepierced male adapter plug was connected to the clave y-site of a primary infusion set, the connection site was tightened, a syringe with an attached needle of unspecified gauge was inserted into the prepierced male adapter plug, and the technician began to manually inject contrast. The prepierced male adapter plug "popped off" from the clave port of the primary infusion set shortly after the injection of contrast had begun. Approximately 50% of the contrast stayed in the syringe, and the remainder landed onto the floor, the staff member's feet and shoes, and the patient's shoe. The customner contact stated that the staff member's feet felt warm from the contrast and she had to wash her feet and shoes. Reportedly, the facility's safety officer was notified of the event, the spill was cleaned per protocol, and the tubing was discarded. The customer contact further indicated that two rooms became contaminated and had to be shut down from (dates unknown). The patient's diagnostic procedure was rescheduled and completed the next day. There was no blood loss or any adverse sequelae to the patient or staff member. Though requested, no additional information provided.
Patient Sequence No: 1, Text Type: D, B5
[7863777]
The actual devices involved in the reported incidents were not returned for analysis. The lot numbers for these products were not identified; therefore, a review of the batch records could not be performed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615050-2004-00130 |
| MDR Report Key | 904791 |
| 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 | 879597 |
| 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 |