UNSPECIFIED BD POLYCARBONATE SYRINGE
Report
- Report Number
- 2243072-2019-01874
- Event Type
- Injury
- Date Received
- August 30, 2019
- Date of Event
- August 12, 2019
- Report Date
- September 6, 2019
- Manufacturer
- BECTON DICKINSON
- Product Code
- FMF
- PMA / PMN Number
- UNKNOWN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
INVESTIGATION SUMMARY: BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION AS NO SAMPLE, LOT, OR BATCH NUMBER WERE PROVIDED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
MATERIAL NO: UNKNOWN BATCH NO: UNKNOWN IT WAS REPORTED THAT AFTER USE OF THE UNSPECIFIED BD¿ POLYCARBONATE SYRINGE THERE WAS FOREIGN MATTER. IT WAS REPORTED VIA AN AMD NEOVASCULAR PART II SYMPOSIUM THAT WHEN USING UNSPECIFIED BD¿ SYRINGE SUCH AS THE BD POLYCARBONATE SYRINGE ¿FLOATERS¿ WERE NOTED FOLLOWING INTRAOCULAR INJECTION OF DRUGS. THE STUDY SUGGESTS THAT THE INJECTIONS BE GIVEN ONLY WITH NON-SILICONE SYRINGES WHEN RECEIVING MULTIPLE BEVACIZUMAB, RANIBIZUMAB AND AFLIBERCEPT INJECTIONS THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SUBJECT OF THE COMPLAINT IS NOT THE MEDSCAPE ARTICLE, BUT RATHER THE ABSTRACT FROM THE AMD NEOVASCULAR PART II SYMPOSIUM REFERENCED AT THE BOTTOM OF THAT ULTIMATELY THIS ABSTRACT REFERENCES ¿FLOATERS¿ FOLLOWING INTRAOCULAR INJECTION OF DRUGS USING THREE IDENTIFIED BD PRODUCTS: BEVACIZUMAB IN 0.3 ML BD POLYPROPYLENE INSULIN SYRINGES (DIABETES CARE) ZANIBIZUMAB IN 1.0 ML BD POLYPROPYLENE TUBERCULIN SYRINGES (MDS) AFLIBERCEPT IN 1.0 ML BD POLYCARBONATE SYRINGES (MDS)" "I'M PASTING THE ABSTRACTS BELOW FOR JOHN THOMPSON'S STUDY. YOU WILL SEE THAT HE SUGGESTS THAT THE INJECTIONS BE GIVEN ONLY WITH NON-SILICONE SYRINGES. I WANTED TO TALK WITH THE APPROPRIATE PERSON AT BD AS TO REACTION TO THE SUGGESTION THAT THESE BD SYRINGES THAT CONTAIN SILICONE OIL SHOULD BE ABANDONED AND WHETHER THERE ARE PLANS AT BD TO CHANGE THE WAY SYRINGES ARE MADE IN LIGHT OF FINDINGS OF THE DROPLETS. AND A COUPLE MORE QUESTIONS AS WELL. COULD YOU LET ME KNOW HOW TO CONNECT WITH THE RIGHT PERSON?" "OBJECTIVE TO COMPARE THE INCIDENCE OF SILICONE OIL MICRODROPLETS IN THE VITREOUS OF EYES WITH 6 OR MORE INTRAVITREAL INJECTIONS OF THE SAME ANTI-VEGF DRUG. PURPOSE THERE IS INCREASING AWARENESS OF SILICONE OIL MICRODROPLETS IN PATIENTS RECEIVING NUMEROUS INTRAVITREAL ANTI-VEGF INJECTIONS. METHODS THIS WAS A PROSPECTIVE CROSS-SECTIONAL STUDY OF 197 CONSECUTIVE EYES RECEIVING ONE OF THREE ANTI-VEGF DRUGS FOR TREATMENT OF CHOROIDAL NEOVASCULARIZATION, DIABETIC MACULAR EDEMA OR MACULAR EDEMA FROM VENOUS OCCLUSIVE DISEASE. ALL TREATMENTS IN THE STUDY EYE HAD TO BE WITH THE SAME DRUG. THE CONTROL GROUP WAS 94 FELLOW EYES WITH NO PRIOR INTRAVITREAL INJECTIONS. THE ANTERIOR AND MID-VITREOUS WERE CAREFULLY EXAMINED BY SLIT LAMP BIOMICROSCOPY AT 12X TO 16X WITH DILATED PUPIL AND OCULAR SACCADES TO DETECT ONE OR MORE SILICONE DROPLETS IN THE VITREOUS. SILICONE OIL DROPLETS WERE GRADED ON A SCALE FROM 0 IF ABSENT TO 4+ IF PRESENT, BASED ON NUMBER AND SIZE OF DROPLETS. RESULTS THE 3 ANTI-VEGF DRUGS WERE DELIVERED WITH DIFFERENT SYRINGES (BEVACIZUMAB IN 0.3 ML BD POLYPROPYLENE INSULIN SYRINGES, RANIBIZUMAB IN 1.0 ML BD POLYPROPYLENE TUBERCULIN SYRINGES OR THE RANIBIZUMAB PREFILLED SYRINGE AND AFLIBERCEPT IN 1.0 ML BD POLYCARBONATE SYRINGES). THE NUMBER OF TREATMENTS WERE SIMILAR. SILICONE MICRODROPLETS WERE DETECTED IN 39/54 EYES (72.2%) RECEIVING BEVACIZUMAB, 14/90 EYES (15.6%) RECEIVING RANIBIZUMAB AND 26/53 EYES (49.1%) RECEIVING AFLIBERCEPT. NO SILICONE OIL MICRODROPLETS WERE FOUND IN 94 CONTROL EYES OR A SUBSET OF 14 EYES TREATED ONLY WITH RANIBIZUMAB PREFILLED SYRINGES. THE DIFFERENCE IN SILICONE MICRODROPLETS INCIDENCE WAS SIGNIFICANT WHEN COMPARING BEVACIZUMAB TO RANIBIZUMAB, AFLIBERCEPT AND CONTROLS (P<.001). THE MEAN SILICONE OIL MICRODROPLETS SEVERITY WAS 1.46 WITH BEVACIZUMAB, 0.09 WITH RANIBIZUMAB AND 0.36 WITH AFLIBERCEPT (P<.001). MOST PATIENTS WERE ASYMPTOMATIC EXCEPT IN EYES WITH 2+ TO 4+ SILICONE OIL MICRODROPLETS. CONCLUSION SILICONE MICRODROPLETS IN EYES RECEIVING MULTIPLE BEVACIZUMAB, RANIBIZUMAB AND AFLIBERCEPT INJECTIONS ARE MORE COMMON THAN PREVIOUSLY REPORTED AND DIFFERED BETWEEN THE THREE DRUGS. INTRAVITREAL INJECTIONS SHOULD BE GIVEN USING SILICONE FREE SYRINGES AND THE USE OF BD INSULIN SYRINGES TO DELIVER BEVACIZUMAB SHOULD BE ABANDONED DUE TO THE HIGH INCIDENCE AND SEVERITY OF SILICONE OIL MICRODROPLETS."
THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.
MATERIAL NO: UNKNOWN BATCH NO: UNKNOWN. IT WAS REPORTED THAT AFTER USE OF THE UNSPECIFIED BD¿ POLYCARBONATE SYRINGE THERE WAS FOREIGN MATTER. IT WAS REPORTED VIA AN AMD NEOVASCULAR PART II SYMPOSIUM THAT WHEN USING UNSPECIFIED BD¿ SYRINGE SUCH AS THE BD POLYCARBONATE SYRINGE ¿FLOATERS¿ WERE NOTED FOLLOWING INTRAOCULAR INJECTION OF DRUGS. THE STUDY SUGGESTS THAT THE INJECTIONS BE GIVEN ONLY WITH NON-SILICONE SYRINGES WHEN RECEIVING MULTIPLE BEVACIZUMAB, RANIBIZUMAB AND AFLIBERCEPT INJECTIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SUBJECT OF THE COMPLAINT IS NOT THE MEDSCAPE ARTICLE, BUT RATHER THE ABSTRACT FROM THE AMD NEOVASCULAR PART II SYMPOSIUM REFERENCED AT THE BOTTOM OF THAT ULTIMATELY THIS ABSTRACT REFERENCES ¿FLOATERS¿ FOLLOWING INTRAOCULAR INJECTION OF DRUGS USING THREE IDENTIFIED BD PRODUCTS: BEVACIZUMAB IN 0.3 ML BD POLYPROPYLENE INSULIN SYRINGES (DIABETES CARE). ZANIBIZUMAB IN 1.0 ML BD POLYPROPYLENE TUBERCULIN SYRINGES (MDS). AFLIBERCEPT IN 1.0 ML BD POLYCARBONATE SYRINGES (MDS)". "I'M PASTING THE ABSTRACTS BELOW FOR (B)(6) STUDY. YOU WILL SEE THAT HE SUGGESTS THAT THE INJECTIONS BE GIVEN ONLY WITH NON-SILICONE SYRINGES. I WANTED TO TALK WITH THE APPROPRIATE PERSON AT BD AS TO REACTION TO THE SUGGESTION THAT THESE BD SYRINGES THAT CONTAIN SILICONE OIL SHOULD BE ABANDONED AND WHETHER THERE ARE PLANS AT BD TO CHANGE THE WAY SYRINGES ARE MADE IN LIGHT OF FINDINGS OF THE DROPLETS. AND A COUPLE MORE QUESTIONS AS WELL. COULD YOU LET ME KNOW HOW TO CONNECT WITH THE RIGHT PERSON?" "OBJECTIVE TO COMPARE THE INCIDENCE OF SILICONE OIL MICRODROPLETS IN THE VITREOUS OF EYES WITH 6 OR MORE INTRAVITREAL INJECTIONS OF THE SAME ANTI-VEGF DRUG. PURPOSE: THERE IS INCREASING AWARENESS OF SILICONE OIL MICRODROPLETS IN PATIENTS RECEIVING NUMEROUS INTRAVITREAL ANTI-VEGF INJECTIONS. METHODS: THIS WAS A PROSPECTIVE CROSS-SECTIONAL STUDY OF 197 CONSECUTIVE EYES RECEIVING ONE OF THREE ANTI-VEGF DRUGS FOR TREATMENT OF CHOROIDAL NEOVASCULARIZATION, DIABETIC MACULAR EDEMA OR MACULAR EDEMA FROM VENOUS OCCLUSIVE DISEASE. ALL TREATMENTS IN THE STUDY EYE HAD TO BE WITH THE SAME DRUG. THE CONTROL GROUP WAS 94 FELLOW EYES WITH NO PRIOR INTRAVITREAL INJECTIONS. THE ANTERIOR AND MID-VITREOUS WERE CAREFULLY EXAMINED BY SLIT LAMP BIOMICROSCOPY AT 12X TO 16X WITH DILATED PUPIL AND OCULAR SACCADES TO DETECT ONE OR MORE SILICONE DROPLETS IN THE VITREOUS. SILICONE OIL DROPLETS WERE GRADED ON A SCALE FROM 0 IF ABSENT TO 4+ IF PRESENT, BASED ON NUMBER AND SIZE OF DROPLETS. RESULTS: THE 3 ANTI-VEGF DRUGS WERE DELIVERED WITH DIFFERENT SYRINGES (BEVACIZUMAB IN 0.3 ML BD POLYPROPYLENE INSULIN SYRINGES, RANIBIZUMAB IN 1.0 ML BD POLYPROPYLENE TUBERCULIN SYRINGES OR THE RANIBIZUMAB PREFILLED SYRINGE AND AFLIBERCEPT IN 1.0 ML BD POLYCARBONATE SYRINGES). THE NUMBER OF TREATMENTS WERE SIMILAR. SILICONE MICRODROPLETS WERE DETECTED IN 39/54 EYES (72.2%) RECEIVING BEVACIZUMAB, 14/90 EYES (15.6%) RECEIVING RANIBIZUMAB AND 26/53 EYES (49.1%) RECEIVING AFLIBERCEPT. NO SILICONE OIL MICRODROPLETS WERE FOUND IN 94 CONTROL EYES OR A SUBSET OF 14 EYES TREATED ONLY WITH RANIBIZUMAB PREFILLED SYRINGES. THE DIFFERENCE IN SILICONE MICRODROPLETS INCIDENCE WAS SIGNIFICANT WHEN COMPARING BEVACIZUMAB TO RANIBIZUMAB, AFLIBERCEPT AND CONTROLS (P<.001). THE MEAN SILICONE OIL MICRODROPLETS SEVERITY WAS 1.46 WITH BEVACIZUMAB, 0.09 WITH RANIBIZUMAB AND 0.36 WITH AFLIBERCEPT (P<.001). MOST PATIENTS WERE ASYMPTOMATIC EXCEPT IN EYES WITH 2+ TO 4+ SILICONE OIL MICRODROPLETS. CONCLUSION: SILICONE MICRODROPLETS IN EYES RECEIVING MULTIPLE BEVACIZUMAB, RANIBIZUMAB AND AFLIBERCEPT INJECTIONS ARE MORE COMMON THAN PREVIOUSLY REPORTED AND DIFFERED BETWEEN THE THREE DRUGS. INTRAVITREAL INJECTIONS SHOULD BE GIVEN USING SILICONE FREE SYRINGES AND THE USE OF BD INSULIN SYRINGES TO DELIVER BEVACIZUMAB SHOULD BE ABANDONED DUE TO THE HIGH INCIDENCE AND SEVERITY OF SILICONE OIL MICRODROPLETS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 746419 | UNSPECIFIED BD POLYCARBONATE SYRINGE | SYRINGE | FMF | BECTON DICKINSON | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |