BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
Report
- Report Number
- 1710034-2023-00883
- Event Type
- Malfunction
- Date Received
- August 7, 2023
- Date of Event
- June 6, 2023
- Report Date
- August 8, 2023
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- UDI-DI
- 00382903825332
- PMA / PMN Number
- K201075
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.6. INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. EXAMINATION OF THE ACTUAL PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10.
THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 11-APR-2023. H.6. INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED TWO CATHETERS ASSEMBLIES OF A 20G X 1.00IN INSYTE AUTOGUARD DEVICE FROM LOT NUMBER 3061023. A GROSS VISUAL INSPECTION SHOWS THAT THE CATHETERS HAD MEDIA INDICATING THAT THEY HAVE BEEN USED. FURTHER MICROSCOPIC INSPECTION SHOWS A CATHETER WITH A DAMAGE THAT HAS THE V-SHAPE FORM NEAR THE TIP. THE OBSERVED DAMAGE IS IDENTICAL TO THAT CREATED WHEN THE NEEDLE PIERCES THE CATHETER WALL NEAR THE TIP GIVING A SPEAR THROUGH, THUS CONFIRMING YOUR REPORTED ISSUE. ALTHOUGH YOUR REPORTED ISSUE WAS CONFIRMED, IT COULD NOT BE DETERMINED IF THE DAMAGE RESULTED FROM THE MANUFACTURING OF THE DEVICE OR FROM THE USER ENVIRONMENT. DURING MANUFACTURING, THIS MAY OCCUR DUE TO THE ALIGNMENT OF THE SET TOGETHER STATION, BENT TUBING, OR AIR BLOW INCONSISTENCY. THERE IS A 100 PERCENT AUTOMATED VISION SYSTEM INSPECTION AND A SAMPLING PLAN IMPLEMENTED FOR TIP SPEAR WHICH MITIGATES THE OCCURRENCE OF THIS DEFECT. HOWEVER, AS THE RETURNED HAS BEEN REMOVED FROM THE PACKAGE AND HANDLED IT IS POSSIBLE THAT THE DEFECTS ORIGINATED DUE TO IMPROPER USE EITHER DURING TIP ADHESION BREAK OR DURING THE VENIPUNCTURE ATTEMPT IN THE CLINICIAN ENVIRONMENT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10.
IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER SPLIT WHILE STARTING THE IV, CAUSING DISCOMFORT TO THE PATIENT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE ALSO HAD PROBLEMS WITH REF # (B)(4)- LOT # 3061023 ¿ THEY HAVE EVIDENTLY BEEN CAUSING DAMAGE TO THE PATIENTS VEINS. ADDITIONAL INFO FROM CUSTOMER: I AM RELYING WITH THE NECESSARY INFORMATION ON BEHALF OF THE NURSES THAT USE THE IV CATHETER. THERE WERE 2 CATHETERS THAT WERE NOTED FROM THE SUPPLY WE HAVE THAT WERE SPLINTERED AT THE NEEDLE INSERTION POINT. IT DID CAUSE PAIN AND DISCOMFORT TO ONE OF OUR PATIENTS. 2 OUT OF 4 CATHETERS USED THAT DAY WERE NOTED TO BE DEFECTIVE. THE FIRST ONE WAS CAUGHT BY THE RN WHO HAS ACTUALLY SEEN THIS PRIOR WITH HER PREVIOUS POSITION AT A HOSPITAL. SHE WAS ABLE TO OPEN ANOTHER IV CATH AND INSERT THAT ONE WITHOUT DEFECT. THE 2ND CASE, THE RN WAS STARTING THE IV AND TRYING TO BREAK THE SKIN WHEN SHE NOTICED THE CATH SPLINTERING AS SHE WAS TRYING TO INSERT. VEIN ACCESS WAS NOT ACHIEVED BUT THIS PATIENT DID FEEL DISCOMFORT WHEN STARTING THAT IV. SPLINTERING WAS NOTED AND IMMEDIATELY THE RN STOPPED USING THAT CATH AND NOTIFIED HER MANAGER FOR THIS REVIEW. THE PATIENT WAS IN THEIR MID 50¿S AND DID NOT EXPERIENCE ANY OTHER ILL EFFECTS OTHER THAN LOCALIZED PAIN. ARE YOU ABLE TO IDENTIFY THE NUMBER OF OCCURRENCE? 2. DID THE EVENT INVOLVE AN URGENT/LIFE THREATENING MEDICAL SITUATION? NO. WHAT IS THE CAUSE OF THE VEINS DAMAGE ON PATIENTS? NO- DID NOT MAKE IT TO VEIN., SPLINTERED GOING THROUGH SKIN. CAN YOU DESCRIBE IN DETAIL ON THE PATIENTS¿ EFFECT? ONE PATIENT HAD DISCOMFORT LEADING TO DISCOVERY OF AFFECTED CATHETER. ARE YOU ABLE TO IDENTIFY ANY DEFECT FOUND ON THE BD PRODUCTS THAT USED ON THAT PATIENTS? NONE. IS THERE ANY PATIENT HARM, INJURY, OR NEGATIVE OUTCOME THAT HAS NOT ALREADY BEEN DISCUSSED? NONE. DID THE EVENT INVOLVE AN URGENT/LIFE THREATENING MEDICAL SITUATION? NO. DOES THE PATIENT HAVE ANY MEDICAL HISTORY THAT WOULD MAKE THEM MORE SUSCEPTIBLE TO VEINS DAMAGE? NONE. DID THE EVENT INTERRUPT THE ADMINISTRATION OF ANY MEDICATION, OR CAUSE A CLINICALLY SIGNIFICANT DELAY IN MEDICATION, THAT NEGATIVELY IMPACTED THE PATIENT? IF YES, PLEASE PROVIDE DETAILS. NONE. DESCRIBE ANY SIGNS, SYMPTOMS, AND/OR COMPLICATIONS THE PATIENT EXPERIENCED. DESCRIBE HOW IT WAS TREATED AND THE PATIENT OUTCOME. NO OUTCOME CHANGES".
IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER SPLIT WHILE STARTING THE IV, CAUSING DISCOMFORT TO THE PATIENT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE ALSO HAD PROBLEMS WITH REF # 382533- LOT # 3061023 ¿ THEY HAVE EVIDENTLY BEEN CAUSING DAMAGE TO THE PATIENTS VEINS... ADDITIONAL INFO FROM CUSTOMER: I AM RELYING WITH THE NECESSARY INFORMATION ON BEHALF OF THE NURSES THAT USE THE IV CATHETER. THERE WERE 2 CATHETERS THAT WERE NOTED FROM THE SUPPLY WE HAVE THAT WERE SPLINTERED AT THE NEEDLE INSERTION POINT. IT DID CAUSE PAIN AND DISCOMFORT TO ONE OF OUR PATIENTS. 2 OUT OF 4 CATHETERS USED THAT DAY WERE NOTED TO BE DEFECTIVE. THE FIRST ONE WAS CAUGHT BY THE RN WHO HAS ACTUALLY SEEN THIS PRIOR WITH HER PREVIOUS POSITION AT A HOSPITAL. SHE WAS ABLE TO OPEN ANOTHER IV CATH AND INSERT THAT ONE WITHOUT DEFECT. THE 2ND CASE, THE RN WAS STARTING THE IV AND TRYING TO BREAK THE SKIN WHEN SHE NOTICED THE CATH SPLINTERING AS SHE WAS TRYING TO INSERT. VEIN ACCESS WAS NOT ACHIEVED BUT THIS PATIENT DID FEEL DISCOMFORT WHEN STARTING THAT IV. SPLINTERING WAS NOTED AND IMMEDIATELY THE RN STOPPED USING THAT CATH AND NOTIFIED HER MANAGER FOR THIS REVIEW. THE PATIENT WAS IN THEIR MID 50¿S AND DID NOT EXPERIENCE ANY OTHER ILL EFFECTS OTHER THAN LOCALIZED PAIN... -ARE YOU ABLE TO IDENTIFY THE NUMBER OF OCCURRENCE? 2... -DID THE EVENT INVOLVE AN URGENT/LIFE THREATENING MEDICAL SITUATION? NO -WHAT IS THE CAUSE OF THE VEINS DAMAGE ON PATIENTS? NO- DID NOT MAKE IT TO VEIN. SPLINTERED GOING THROUGH SKIN -CAN YOU DESCRIBE IN DETAIL ON THE PATIENTS¿ EFFECT? ONE PATIENT HAD DISCOMFORT LEADING TO DISCOVERY OF AFFECTED CATHETER -ARE YOU ABLE TO IDENTIFY ANY DEFECT FOUND ON THE BD PRODUCTS THAT USED ON THAT PATIENTS? NONE... -IS THERE ANY PATIENT HARM, INJURY, OR NEGATIVE OUTCOME THAT HAS NOT ALREADY BEEN DISCUSSED? NONE -DID THE EVENT INVOLVE AN URGENT/LIFE THREATENING MEDICAL SITUATION? NO -DOES THE PATIENT HAVE ANY MEDICAL HISTORY THAT WOULD MAKE THEM MORE SUSCEPTIBLE TO VEINS DAMAGE? NONE -DID THE EVENT INTERRUPT THE ADMINISTRATION OF ANY MEDICATION, OR CAUSE A CLINICALLY SIGNIFICANT DELAY IN MEDICATION, THAT NEGATIVELY IMPACTED THE PATIENT? IF YES, PLEASE PROVIDE DETAILS. NONE -DESCRIBE ANY SIGNS, SYMPTOMS, AND/OR COMPLICATIONS THE PATIENT EXPERIENCED. DESCRIBE HOW IT WAS TREATED AND THE PATIENT OUTCOME. NO OUTCOME CHANGES".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1458467 | BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 3061023 | 00382903825332 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Unknown |