BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM
Report
- Report Number
- 9610847-2023-00095
- Event Type
- Malfunction
- Date Received
- May 3, 2023
- Date of Event
- April 12, 2023
- Report Date
- June 28, 2023
- Manufacturer
- BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
- Product Code
- FOZ
- PMA / PMN Number
- K173354
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: (B)(6) 2023 H6: INVESTIGATION SUMMARY IT WAS REPORTED THE VENT PLUG WAS LOOSE IN THE PACKAGE RESULTING IN BLOOD EXPOSURE. TO AID IN THE INVESTIGATION, SEVENTEEN UNOPENED SAMPLES AND THREE PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. AN EVALUATION WAS PERFORMED ON THE SAMPLES. TEN SAMPLES HAD THE VENT PLUG PRESENT AND ASSEMBLED CORRECTLY. SEVEN SAMPLE HAD THE VENT PLUG LOOSE. THE SAMPLES WITH THE LOOSE VENT PLUG WERE INSPECTED FOR ANY DAMAGE TO THE LUER THAT MAY HAVE INDUCED THE INCORRECT ASSEMBLY. HOWEVER, NO DAMAGE TO THE LUER OR VENT PLUG WAS OBSERVED. THIS DEFECT CAN BE ATTRIBUTED TO THE MANUAL FINAL ASSEMBLY DURING THE MANUFACTURING PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER (B)(4) , LOT 2241423. THE REVIEW REVEALED THERE WERE NO INTERNAL REJECTS RELATED TO THE REPORTED ISSUE BY THE CUSTOMER. ACCORDING TO THE QUALITY RECORDS ALL THE INSPECTIONS OF THE SAMPLING PLAN MET THE ACCEPTANCE CRITERIA. THIS LOT WAS ASSEMBLED BY MEANS OF TWO FINAL ASSEMBLIES. AN AUTOMATIC FINAL ASSEMBLY IN WHICH THERE IS A SENSOR THAT IS RESPONSIBLE FOR VERIFYING THE PRESENCE OF VENT PLUG AT THE TIME OF ASSEMBLY. THIS PROCESS IS ALSO RESPONSIBLE FOR APPLYING A TORQUE TO THE VENT PLUG INSIDE THE LUER BY CONTROLLED PRESSURE TO ENSURE THE CORRECT ASSEMBLY OF THE VENT PLUG. THE OTHER ASSEMBLY IS A MANUAL ASSEMBLY WHERE THE VENT PLUG ASSEMBLY PROCESS IS PERFORMED MANUALLY BY APPLYING MINIMAL FORCE TO ENSURE THAT THE VENT PLUG HAS BEEN ASSEMBLED CORRECTLY. BASED ON THE INVESTIGATION, BD WAS ABLE TO CONFIRM THE REPORTED DEFECT. H3 OTHER TEXT : SEE H10.
IT WAS REPORTED THAT 9 BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM AIR FILTER WAS NOT CONNECT AND CAUSE BLOOD EXPOSURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE AIR FILTER IS NOT CONNECTED TO NEXIVA DIFFUSICS, BUT IS LOOSE IN THE PACKAGE. THE STAFF IS NOT AWARE OF THIS, SINCE THE AIR FILTER NORMALLY IS CONNECTED TO THE NEXIVA DIFFUSCS. THE RESULT OF THIS OCCUR WAS 9 TIMES BLOOD EXPOSURE FOR THE STAFF. THE STAFF IS EXPERIENCED AND THEY HAVE BEEN USING NEXIVA DIFFUSICS FOR SEVERAL YEARS. DURING USE.
IT WAS REPORTED THAT 9 BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM AIR FILTER WAS NOT CONNECT AND CAUSE BLOOD EXPOSURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE AIR FILTER IS NOT CONNECTED TO NEXIVA DIFFUSICS, BUT IS LOOSE IN THE PACKAGE. THE STAFF IS NOT AWARE OF THIS, SINCE THE AIR FILTER NORMALLY IS CONNECTED TO THE NEXIVA DIFFUSCS. THE RESULT OF THIS OCCUR WAS 9 TIMES BLOOD EXPOSURE FOR THE STAFF. THE STAFF IS EXPERIENCED AND THEY HAVE BEEN USING NEXIVA DIFFUSICS FOR SEVERAL YEARS. DURING USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 433750 | BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM | INTRAVASCULAR CATHETER | FOZ | BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. | 2241423 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |