BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER
Report
- Report Number
- 1710034-2020-00469
- Event Type
- Malfunction
- Date Received
- July 21, 2020
- Date of Event
- July 1, 2020
- Report Date
- August 24, 2020
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- UDI-DI
- 30382903826446
- PMA / PMN Number
- K110443
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
CORRECTION: THE LOT NUMBERS PROVIDED COULD NOT BE CONFIRMED BY THE CUSTOMER. THE FOLLOWING FIELDS HAVE BEEN UPDATED: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT BLOOD SPLASHED OFF THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER AND ONTO THE CUSTOMER WHEN RETRACTING THE NEEDLE DURING USE. D.2. MEDICAL DEVICE LOT#: UNKNOWN.
H.6. INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. THE DHR FOR EITHER POSSIBLE LOT WAS REVIEWED (8232796 AND 8151980). NO RELATED QUALITY ISSUES OR PROCESS DEVIATIONS WERE FOUND. THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED.
IT WAS REPORTED THAT BLOOD SPLASHED OFF THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER AND ONTO THE CUSTOMER WHEN RETRACTING THE NEEDLE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER STATED THAT THE 18G INSYTE AUTOGUARD BLOOD CONTROL HAVE SPLATTERED BLOOD ON THEM WHEN THEY GO TO RETRACT THE NEEDLE. THEY WEREN'T SURE WHAT LOT NUMBER IT COULD HAVE BEEN SO THEY GAVE ME THE ONLY TWO LOT NUMBERS THEY HAD. THEY ARE CONCERNED ABOUT BLOOD SPLATTERING ON THEM AS THEY HIT THE SAFETY BUTTON."
IT WAS REPORTED THAT BLOOD SPLASHED OFF THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER AND ONTO THE CUSTOMER WHEN RETRACTING THE NEEDLE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER STATED THAT THE 18G INSYTE AUTOGUARD BLOOD CONTROL HAVE SPLATTERED BLOOD ON THEM WHEN THEY GO TO RETRACT THE NEEDLE. THEY WEREN'T SURE WHAT LOT NUMBER IT COULD HAVE BEEN SO THEY GAVE ME THE ONLY TWO LOT NUMBERS THEY HAD. THEY ARE CONCERNED ABOUT BLOOD SPLATTERING ON THEM AS THEY HIT THE SAFETY BUTTON."
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8232796. MEDICAL DEVICE EXPIRATION DATE: 2021-08-31. DEVICE MANUFACTURE DATE: 2018-08-21. MEDICAL DEVICE LOT #: 8151980. MEDICAL DEVICE EXPIRATION DATE: 2021-05-31. DEVICE MANUFACTURE DATE: 2018-05-31. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).
IT WAS REPORTED THAT BLOOD SPLASHED OFF THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER AND ONTO THE CUSTOMER WHEN RETRACTING THE NEEDLE DURING USE. LOT#'S 8232796 AND 8151980 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER STATED THAT THE 18G INSYTE AUTOGUARD BLOOD CONTROL HAVE SPLATTERED BLOOD ON THEM WHEN THEY GO TO RETRACT THE NEEDLE. THEY WEREN'T SURE WHAT LOT NUMBER IT COULD HAVE BEEN SO THEY GAVE ME THE ONLY TWO LOT NUMBERS THEY HAD. THEY ARE CONCERNED ABOUT BLOOD SPLATTERING ON THEM AS THEY HIT THE SAFETY BUTTON."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 770096 | BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 382644 | UNKNOWN | 30382903826446 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |