IV CATHETER
Report
- Report Number
- 1118880-2015-00024
- Event Type
- Injury
- Date Received
- July 15, 2015
- Date of Event
- June 15, 2015
- Report Date
- July 15, 2015
- Manufacturer
- TERUMO MEDICAL CORPORATION
- Product Code
- FOZ
- PMA / PMN Number
- K891087
- Removal / Correction Number
- 1118880-2015-001R
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP # 2 FOR MFG. REPORT # 1118880-2015-00024 TO ATTACH MEDWATCH REPORT NUMBER 5043151, WHICH WAS RECEIVED BY TERUMO FROM THE FDA ON JULY 21, 2015. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.
ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.
THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP # 3 TO PROVIDE ADDITIONAL INVESTIGATION RESULTS. AT THIS POINT IN TIME, A DEFINITIVE ROOT CAUSE OF THE SHEATH/CATHETER BREAKAGE CANNOT BE DETERMINED. HOWEVER, BASED ON THE INVESTIGATION RESULTS, THE POTENTIAL OF A MANUFACTURING RELATED CAUSE CANNOT BE RULED OUT. THE DEFECT COULD NOT BE RECREATED UNDER NORMAL ASSEMBLY CONDITIONS DUE TO THE DECOMMISSIONING OF THE SR ASSEMBLY MACHINES. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.
THE ACTUAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. HOWEVER 22 UN-USED SAMPLES FROM THE REPORTED LOT WERE RETURNED FOR EVALUATION. A PHOTO OF THE ACTUAL SAMPLE WAS PROVIDED. THEREFORE, THE INVESTIGATION CONSISTED OF EVALUATION OF USER FACILITY INFORMATION, A PHOTOGRAPH OF THE INVOLVED SAMPLE, 22 UNUSED SAMPLES, AND THE RESERVE SAMPLES FROM THE REPORTED LOT AND SURROUNDING LOTS. A VISUAL EVALUATION OF THE PHOTO CONFIRMED THE CATHETER TUBING WAS SEVERED. THE CATHETER TUBING APPEARS TO BE CUT AT ABOUT 5 MM FROM THE HUB. IT APPEARS TO BE MISSING ABOUT 20-21MM OF THE CATHETER TUBING. THE TUBING DOES NOT APPEAR TO HAVE JAGGED EDGES OR HAVING BEEN STRETCHED IN THE PHOTO, HOWEVER IT APPEARS TO BE A STRAIGHT CLEAN CUT WITH TWO DISTINCT CREASES 180 DEGREES APART WITH SLIGHT DEFORMATION OF THE CROSS SECTION SHAPE TO BE OVAL. 22 UN-USED RETURN SAMPLE FROM THE REPORTED LOT. A VISUAL EXAMINATION OF THE 22 UN-USED SAMPLES REVEALED NO DEFECTS. CATHETER JOINT STRENGTH WAS PERFORMED AND MET MANUFACTURER SPECIFICATIONS. AN EVALUATION OF THE RETENTION SAMPLES WAS CONDUCTED FOR THE REPORTED LOT ALONG WITH THE SAMPLES FROM THE SURROUNDING LOTS. A VISUAL EXAMINATION OF THE RETENTION SAMPLES AND SURROUNDING LOTS REVEALED NO DEFECTS. CATHETER JOINT STRENGTH WAS PERFORMED AND MET MANUFACTURER SPECIFICATIONS. A TEST WAS CONDUCTED TO REPRODUCE THE DEFECT USING STERILIZED RETENTION SAMPLES. SAMPLES WERE SUBJECTED TO SIMULATION OF DIFFERENT CONDITIONS AND SUBJECTED TO PULL TESTS CONSEQUENTLY TO REPRODUCE THE FAILURE SYMPTOMS. THIRTY SAMPLES WERE UTILIZED TO SIMULATE SIX DIFFERENT SCENARIOS. BASED ON THE SIMULATION RESULTS, THE CATHETER TUBING TENDS TO STRETCH AND BECOME JAGGED WHEN SUBJECTED TO PULL FORCE AFTER BEING IN DIFFERENT SIMULATED CONDITIONS. A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THAT THERE WERE NO PRODUCTION RELATED PROBLEMS FOR THE REPORTED PRODUCT/LOT NUMBER COMBINATION. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THE REPORTED PRODUCT/LOT# COMBINATION HAS NOT BEEN REPORTED PREVIOUSLY. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. ALTHOUGH THE EXACT CAUSE CANNOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION, BASED ON THE INVESTIGATIONS FINDINGS, IT IS LIKELY THE CATHETER CAME INTO CONTACT WITH A SHARP OBJECT DURING PROCEDURE. ADDITIONALLY WE WERE UNABLE TO DUPLICATE THE FAILURE MODE THROUGH NORMAL USE SIMULATION. ALL CURRENTLY AVAILABLE INFORMATION HAS BEEN PLACED ON FILE BY QUALITY ASSURANCE AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW UP. (B)(4).
THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP # 2 FOR MFG. REPORT # 1118880-2015-00024 TO ATTACH MEDWATCH REPORT NUMBER 5043151, WHICH WAS RECEIVED BY TERUMO FROM THE FDA ON JULY 21, 2015.
THIS REPORT IS BEING SUBMITTED AS FOLLOW UP #1 FOR MFG. REPORT # 1118880-2015-00024 TO (1) STATE THE INITIAL REPORT WAS SUBMITTED IN RESPONSE TO A MEDWATCH REPORT THAT WAS RECEIVED BY TERUMO ON JUNE 16, 2015. THERE WAS NO UF/IMPORTER REPORT # DOCUMENTED ON THE K3500 FORM. (2) ATTACH THE MEDWATCH REPORT. (3) PROVIDE RELEVANT TESTS. (4) PROVIDE OTHER RELEVANT HISTORY. (5) PROVIDE OTHER (CONCOMITANT) MEDICAL PRODUCTS.
THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP # 3 TO PROVIDE ADDITIONAL INVESTIGATION RESULTS.
THE USER FACILITY REPORTED A PATIENT INJURY WHILE USING THE SURFLO CATHETER DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: A SURFLO IV CATHETER WAS USED TO SEDATE THE PATIENT TO REMOVE A WISDOM TOOTH THAT WAS PREVENTING ERUPTION OF THE PATIENTS SECOND MOLAR (#15). THE IV ACCESS WAS OBTAINED IN THE RIGHT LATERAL ACF. IT WENT IN SMOOTHLY AND FLOWED WELL THROUGHOUT THE PROCEDURE. THE SURGERY WAS COMPLETED AND THE PATIENT RECOVERED. THE PATIENT WAS CLOSE TO DISCHARGE, ATTEMPTS TO REMOVE THE IV WERE ABORTED. IT WAS FELT THAT IT WAS "STUCK/HELD" BY SOMETHING; IT WAS TETHERED IN SOME WAY. THE DOCTOR CHOSE TO SPIN THE CATHETER IN AN ATTEMPT TO REMOVE IT, AND WHEN DOING SO, IT SEEMED TO RELEASE, BUT PROXIMAL 5-6MM CLOSEST TO THE HUB CAME OUT. THE GREATER PORTION OF THE CATHETER WAS STILL IN THE PATIENTS VEIN. IMMEDIATELY PROXIMAL PRESSURE WAS APPLIED TO TRY AND PREVENT IT FROM BEING CARRIED CENTRALLY TO THE HEART AND THEN THE LUNGS. THE PATIENT BECAME UNDERSTANDABLY ANXIOUS AND BEGAN MOVING. THE DOCTOR CHOOSE TO PUT A TOURNIQUET ON THE PROXIMAL PART OF THE PATIENTS RIGHT ARM, AND PLACED A NEW IV IN LEFT ARM, AND SEDATED THE PATIENT ONCE AGAIN. ONCE THE PATIENT WAS QUIET AND STILL, THE DOCTOR RELEASED THE TOURNIQUET, AND HAD THE STAFF APPLY PROXIMAL PRESSURE AGAIN ABOVE THE ACF. THE SITE WAS LOCALLY ANESTHETIZED THE WITH LIDOCAINE AND UTILIZED A 15C BLADE TO ATTEMPT TO GET ENOUGH ACCESS, SO THE DOCTOR COULD GRAB IT WITH MOSQUITO FORCEPS BUT WAS UNABLE TO RETRIEVE IT. THE DOCTOR OPENED THE SITE VERTICALLY ABOUT 1CM TOTAL. AFTER A FEW MINUTES OF BLUNT EXPLORATION WITH THE MOSQUITO, THE DOCTOR COULD NO LONGER CONFIDENTLY FEEL WHAT WAS THOUGHT TO BE THE CATHETER. IT WAS REPORT THE DOCTOR FELT THE RADIOGRAPHIC VERIFICATION WAS GOING TO BE NEEDED TO LOCALIZE THE REMAINING CATHETER, SO THE PATIENT WAS TRANSPORTED VIA EMS TO THE LOCAL ED. ONCE THERE, PLAIN FILMS OF THE ARM AND CHEST WERE UNABLE TO LOCALIZE THE CATHETER. AN ULTRASOUND WAS PERFORMED OF THE RIGHT ARM PROXIMAL TO THE IV SITE, AND IT DID NOT REVEAL THE CATHETER EITHER. A CHEST AND ARM CT WERE THEN PERFORMED. ALTHOUGH NOT INITIALLY SEEN ON READING OF THE EXAM, REFORMATTED SCANS, SEVERAL MINUTES LATER REVEALED THAT THE CATHETER WAS LODGED IN AN "ANCILLARY" BRANCH OFF OF THE RIGHT SUBCLAVIAN VEIN, AND WAS NOT IN THE CARDIAC OR PULMONARY SYSTEM. THE RADIOLOGIST SUGGESTED THAT A FOLLOW UP EXAMINATION WITH A PEDIATRIC CARDIOTHORACIC SURGEON AND/OR PEDIATRIC INTERVENTIONAL RADIOLOGIST WAS THE BEST NEXT OPTION FOR REMOVAL OF THE CATHETER. THE NEXT DAY, THE PATIENT SAW A PEDIATRIC INTERVENTIONAL CARDIOLOGIST. IT WAS REPORTED THAT IT IS UNLIKELY THAT THIS WILL MOVE FROM THIS VEIN, AND THAT IT IS HIGHLY UNLIKELY THAT IT WILL EVER CAUSE ANY PROBLEMS, WHETHER IT STAYS WERE IT IS AT, OR MOBILIZES. THE DOCTOR SEEN THE PATIENT ON (B)(6) AND WAS REPORTED DOING "WELL" FROM BOTH THE ORAL SURGERY AND FROM THE INCISION CREATED IN AN ATTEMPT TO RETRIEVE THE RETAINED CATHETER. THREE SUTURES WERE REMOVED, AND THE INCISION WAS HEALING WELL. PATIENT SHOULD BE INCONSEQUENTIAL IN A FEW MONTHS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 458897 | IV CATHETER | IV CATHETER | FOZ | TERUMO MEDICAL CORPORATION | NA | RF2727 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR | Other| R |