BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 22GA
Report
- Report Number
- 1710034-2022-00058
- Event Type
- Injury
- Date Received
- February 8, 2022
- Date of Event
- January 24, 2022
- Report Date
- February 18, 2022
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- PMA / PMN Number
- K201075
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
A SAMPLE IS AVAILABLE FOR EVALUATION. 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: INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE SAMPLE SUBMITTED FOR EVALUATION. BD RECEIVED ONE USED 22G INSYTE AUTOGUARD BC PRO DEVICE WITH NO PRODUCT PACKAGING TO INDICATE A LOT NUMBER. HOWEVER, LOT NUMBER 1133071 WAS IN THE INITIAL REPORT. AN EXTENSION SET WAS ALSO RETURNED ALONG WITH THE CATHETER. A VISUAL INSPECTION OF THE RETURNED SAMPLE FOUND THAT THERE WAS A BREAK IN THE CATHETER TUBING NEAR THE NOSE OF THE ADAPTER. THE REPORTED DEFECT WAS CONFIRMED. FURTHER MICROSCOPIC INSPECTION FOUND THAT THE CATHETER TUBING BROKE OFF AT AN ANGLE. THE SURFACE OF THE BREAK HAD A MOSTLY SMOOTH SURFACE WITH STRIATIONS PRESENT IN A SEGMENT OF THE SURFACE. ONE OF THE ENDS OF THE SURFACE HAD A ROUGH EDGE. THE SMOOTH SURFACE AND STRIATIONS LIKELY INDICATE THAT THE CATHETER TUBING WAS PARTIALLY DAMAGED BY A SHARP INSTRUMENT. THE DAMAGE WAS THEN MOST LIKELY EXACERBATED BY TENSILE STRESS WHICH CREATED THE ROUGH EDGE SEEN ON THE TUBING. BASED ON THE REPORT THE IV WAS PLACED PRIOR TO THE DEFECT BEING IDENTIFIED. IF THE TUBING WAS CUT OR DAMAGED DURING MANUFACTURING, LEAKAGE WOULD MOST LIKELY HAVE BEEN OBSERVED RIGHT AFTER THE NEEDLE WAS RETRACTED DURING PLACEMENT. THIS INFORMATION IN ADDITION TO THE MICROSCOPIC OBSERVATIONS MADE, MAKE IT LIKELY THAT THIS DEFECT OCCURRED IN THE USER ENVIRONMENT AS A RESULT OF COMING INTO CONTACT WITH A SHARP INSTRUMENT (E.G., SCISSORS). SCISSORS OR OTHER SHARP INSTRUMENTS MAY DAMAGE THE CATHETER IF USED AT OR NEAR THE INSERTION SITE, AS STATED IN THE INSTRUCTIONS FOR USE. 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.
IT WAS REPORTED WHILE USING BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 22GA 1.00IN A CATHETER SEPARATED AND REMAINED INSIDE THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AROUND 12:00 ON 01/24, THE CATHETER WAS PLACED FOR A PATIENT AND ADMINISTRATION OF AN ANTIBIOTIC AGENT WAS STARTED. AT 18:00 ON 01/24, THE HCP NOTICED THAT THE FLUID HADN¿T FLOW. THE HCP THEN REMOVED THE INDWELLING CATHETER AND CONFIRMED THAT THE CATHETER HAD BEEN SEPARATED. THE CATHETER REMAINING INTO THE BODY COULD BE TAKEN OUT SAFELY BY SURGERY. THIS ISSUE HAD NOT BEEN NOTICED DURING THE PERIOD FROM ABOUT 12:00, THE TIME OF CATHETER PLACEMENT, TO 18:00. THE POSSIBLE LOT# IS 1133071.
IT WAS REPORTED WHILE USING BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 22GA 1.00IN A CATHETER SEPARATED AND REMAINED INSIDE THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AROUND 12:00 ON 01/24, THE CATHETER WAS PLACED FOR A PATIENT AND ADMINISTRATION OF AN ANTIBIOTIC AGENT WAS STARTED. AT 18:00 ON 01/24, THE HCP NOTICED THAT THE FLUID HADN¿T FLOW. THE HCP THEN REMOVED THE INDWELLING CATHETER AND CONFIRMED THAT THE CATHETER HAD BEEN SEPARATED. THE CATHETER REMAINING INTO THE BODY COULD BE TAKEN OUT SAFELY BY SURGERY. THIS ISSUE HAD NOT BEEN NOTICED DURING THE PERIOD FROM ABOUT 12:00, THE TIME OF CATHETER PLACEMENT, TO 18:00. THE POSSIBLE LOT# IS 1133071.
IT WAS REPORTED WHILE USING BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 22GA 1.00IN A CATHETER SEPARATED AND REMAINED INSIDE THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AROUND 12:00 ON (B)(6), THE CATHETER WAS PLACED FOR A PATIENT AND ADMINISTRATION OF AN ANTIBIOTIC AGENT WAS STARTED. AT 18:00 ON (B)(6), THE HCP NOTICED THAT THE FLUID HADN¿T FLOW. THE HCP THEN REMOVED THE INDWELLING CATHETER AND CONFIRMED THAT THE CATHETER HAD BEEN SEPARATED. THE CATHETER REMAINING INTO THE BODY COULD BE TAKEN OUT SAFELY BY SURGERY. THIS ISSUE HAD NOT BEEN NOTICED DURING THE PERIOD FROM ABOUT 12:00, THE TIME OF CATHETER PLACEMENT, TO 18:00. THE POSSIBLE LOT# IS 1133071.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 757638 | BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 22GA | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 1133071 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |