MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-02-02 for WAMPOLE LABORATORIES manufactured by Wampole Laboratories Div, Caster-wallace, Inc..
[16658]
Phlebotomist was drawing blood from hiv pt. Upon finishing bloodcultures, she began isolator tubes for afb. She filled first isolator and then took second isolator to fill it but encountered difficulty. As a result she used a 10 cc syringe and needle to spare the pt another stick. The phlebotomist upon drawing the blood, subsequently inserted the needle into the stopper of the isolator tube. She picked the tube up with her right hand and tapped the plunger of the syringe with her left thumb to get it staerted. And she did this, the tube exploded sending a pressurized misty spray of blood into her faceand eyes. The tube and syringe were placed in the biohazard bucket on the wall of the pt's room. The box was later impounded. The employee phlebotomist fkushed her eyes with water and then sought treatment in the emergency department. The mfg representative was notified and the remaining tubes of the lot impounded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 30995 |
| MDR Report Key | 30995 |
| Date Received | 1996-02-02 |
| Date of Report | 1995-05-02 |
| Date of Event | 1995-04-20 |
| Date Facility Aware | 1995-04-20 |
| Report Date | 1995-05-02 |
| Date Reported to Mfgr | 1995-05-02 |
| Date Added to Maude | 1996-03-12 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WAMPOLE LABORATORIES |
| Generic Name | ISOLATOR MICROBIAL TUBE |
| Product Code | JSC |
| Date Received | 1996-02-02 |
| Lot Number | 017278 |
| ID Number | PO# 319541 (3/28/95) |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 MO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 32051 |
| Manufacturer | WAMPOLE LABORATORIES DIV, CASTER-WALLACE, INC. |
| Manufacturer Address | HALF ACRE ROAD P.O. BOX 1001 CRANSBURY NJ 08512 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-02-02 |