BD INSYTE-N AUTOGUARD SHIELDED IV CATHETER
Report
- Report Number
- 1710034-2020-00544
- Event Type
- Malfunction
- Date Received
- August 29, 2020
- Date of Event
- August 6, 2020
- Report Date
- September 25, 2020
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- UDI-DI
- 30382903815112
- PMA / PMN Number
- K952861
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
H.6. INVESTIGATION: TWO RETRACTED NEEDLE/BARREL ASSEMBLIES A 24 G CATHETER/ADAPTER ASSEMBLY, ONE OPENED EMPTY PACKAGE AND A PACKAGE LABEL BOTH FROM CATALOG NUMBER 381511, LOT NUMBER 0085145 AND ONE USED 24 G CATHETER/ADAPTER ASSEMBLY AND AN OPENED EMPTY PACKAGE FROM CATALOG NUMBER 381511, LOT NUMBER 0080379 WITH "COVID ROOM" WRITTEN ON THE BAG. OUR PLANTS DO NOT ACCEPT SAMPLES FROM A KNOWN COVID PATIENT OR ROOM. THE SAMPLES WERE DESTROYED. THEREFORE, BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION TO VERIFY THE REPORTED ISSUE. SINCE, AN INVESTIGATION COULD NOT BE PERFORMED BD WAS UNABLE TO DETERMINE A POSSIBLE ROOT CAUSE. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION.
IT WAS REPORTED THAT THE BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER WAS DAMAGED AND DIDN'T LAST AS LONG AS NORMAL. ADDITIONALLY, THE CATHETER CAUSED INFILTRATION AND LEAKING AROUND THE TOP. LOTS 0085145 AND 0080379 WERE REPORTED TO HAVE BEEN INVOLVED IN ALL THESE EVENTS, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PIV IS NOT LAST AS LONG AS NORMAL. WE HAVE HAD SOME THAT LAST 2 HOURS AND SOME THAT LAST 8. WE ARE GETTING MORE INFILTRATES THEN OUR TYPICAL AND LEAKING AROUND THE TOP OF THE CATHETER." "THE WEEKS OF JULY 12TH IS WHEN WE FIRST STARTED NOTICING IT AND IT HAS CONTINUED SINCE." "IN THE PAST 2 WEEKS THEY HAVE NOTICED THIS ITEM AND TWO LOT # NOT LASTING LIKE THEY TYPICALLY DO FOR THEIR PATIENT NEEDS. SOMETIMES USING 3 PIVS/DAY/PATIENT."
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 #: 0085145, MEDICAL DEVICE EXPIRATION DATE: 2023-02-28, DEVICE MANUFACTURE DATE: 2020-03-26, MEDICAL DEVICE LOT #: 0080379, MEDICAL DEVICE EXPIRATION DATE: 2023-02-28, DEVICE MANUFACTURE DATE: 2020-03-24. 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 THE BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER WAS DAMAGED AND DIDN'T LAST AS LONG AS NORMAL. ADDITIONALLY, THE CATHETER CAUSED INFILTRATION AND LEAKING AROUND THE TOP. LOTS 0085145 AND 0080379 WERE REPORTED TO HAVE BEEN INVOLVED IN ALL THESE EVENTS, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PIV IS NOT LAST AS LONG AS NORMAL. WE HAVE HAD SOME THAT LAST 2 HOURS AND SOME THAT LAST 8. WE ARE GETTING MORE INFILTRATES THEN OUR TYPICAL AND LEAKING AROUND THE TOP OF THE CATHETER." "THE WEEKS OF JULY 12TH IS WHEN WE FIRST STARTED NOTICING IT AND IT HAS CONTINUED SINCE." "IN THE PAST 2 WEEKS THEY HAVE NOTICED THIS ITEM AND TWO LOT # NOT LASTING LIKE THEY TYPICALLY DO FOR THEIR PATIENT NEEDS. SOMETIMES USING 3 PIVS/DAY/PATIENT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 933862 | BD INSYTE-N AUTOGUARD SHIELDED IV CATHETER | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 381511 | SEE SECTION H.10. | 30382903815112 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |