INSYTE AUTOG BC GLOBAL BL 22GA X 1.0IN
Report
- Report Number
- 2243072-2023-02139
- Event Type
- Malfunction
- Date Received
- December 5, 2023
- Date of Event
- October 8, 2023
- Report Date
- March 22, 2024
- Manufacturer
- BECTON DICKINSON
- Product Code
- FOZ
- PMA / PMN Number
- UKN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 38102314 AND LOT NUMBER 3129222. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. BASED ON THE AVAILABLE INFORMATION, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.
PENDING INVESTIGATION RESULTS WITH THE NEW MATERIAL NUMBER AND BATCH NUMBER.
H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION A SUPPLEMENTAL REPORT WILL BE FILED.
NO NEW INFORMATION.
PERIPHERAL CATHETER SAFETY DEVICE WHEN TRIGGERED DID NOT WORK. CNPJ NUMBER: (B)(6). CORPORATE NAME: (B)(6). ICMS TAXPAYER (YES/NO): EXEMPT. IF ICMS TAXPAYER, ISSUER OF INVOICE (YES/NO): PRODUCT PURCHASE INVOICE NUMBER: SECTOR/DEPARTMENT: (B)(6) PHARMACY. FULL ADDRESS: (B)(6). CONTACT NAME/PHONE NUMBER: (B)(6). IS THE SAMPLE CONTAMINATED? NO. COULD YOU SEND PHOTOS OF THE SAMPLE? WAS THERE NOTIFICATION TO ANVISA? IF SO, WHAT IS THE NOTIFICATION NUMBER? NO. WHAT IS THE BATCH AND CATALOG OF THE PRODUCT? 3129222. HOW MUCH PRODUCT IS AFFECTED? 1. WAS THE REPORTED INCIDENT NOTICED BEFORE, DURING OR AFTER USE ON THE PATIENT? DURING WAS THERE ANY HARM TO THE PATIENT/HEALTHCARE PROFESSIONAL? EMPLOYEE PUNCTURED HERSELF BECAUSE THE SAFETY DEVICE DID NOT WORK. WAS THERE A NEED FOR MEDICAL AND/OR SURGICAL INTERVENTION DUE TO WHAT HAPPENED (IMAGING EXAMS, SURGERY, MEDICATION ADMINISTRATION, ETC.)? NO. WAS THERE EXPOSURE OF BLOOD OR CHEMOTHERAPY TO MUCOUS MEMBRANES (EYES, NOSE AND MOUTH) OR SKIN? IF SO, INFORM WHETHER THE EXPOSURE WAS TO THE PATIENT OR THE PROFESSIONAL AND WHAT MEASURES WERE ADOPTED. CAT. WHAT MEDICATION WAS BEING ADMINISTERED? IS THE INCIDENT-RELATED SAMPLE AVAILABLE FOR ANALYSIS? IF SO, HOW MANY UNITS? (WE COLLECT A MAXIMUM OF 10 UNITS FOR ANALYSIS PURPOSES) NO. EVENT OCCURRENCE DATE: 10/08/20223. DID THE INCIDENT OCCUR IN A HOSPITAL/INSTITUTION? IF SO, MENTION THE NAME. (B)(6).
IT WAS REPORTED THAT BD UNDISCLOSED PIVC DEVICE NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM PORTUGUESE TO ENGLISH: PERIPHERAL CATHETER SAFETY DEVICE WHEN TRIGGERED DID NOT WORK. HOW MUCH PRODUCT IS AFFECTED? 1 WAS THE REPORTED INCIDENT NOTICED BEFORE, DURING OR AFTER USE ON THE PATIENT? DURING WAS THERE ANY HARM TO THE PATIENT/HEALTHCARE PROFESSIONAL? EMPLOYEE PUNCTURED HERSELF BECAUSE THE SAFETY DEVICE DID NOT WORK. WAS THERE A NEED FOR MEDICAL AND/OR SURGICAL INTERVENTION DUE TO WHAT HAPPENED (IMAGING EXAMS, SURGERY, MEDICATION ADMINISTRATION, ETC.)? NO WAS THERE EXPOSURE OF BLOOD OR CHEMOTHERAPY TO MUCOUS MEMBRANES (EYES, NOSE AND MOUTH) OR SKIN? IF SO, INFORM WHETHER THE EXPOSURE WAS TO THE PATIENT OR THE PROFESSIONAL AND WHAT MEASURES WERE ADOPTED. CAT
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2123161 | INSYTE AUTOG BC GLOBAL BL 22GA X 1.0IN | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON | 3129222 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |