25 G X 1 IN. ECLIPSE NEEDLE SMARTSLIP
Report
- Report Number
- 3002682307-2021-00455
- Event Type
- Malfunction
- Date Received
- September 1, 2021
- Date of Event
- August 3, 2021
- Report Date
- May 31, 2022
- Manufacturer
- BECTON DICKINSON, S.A.
- Product Code
- FMI
- UDI-DI
- 50382903058919
- PMA / PMN Number
- K100209
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2102002. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS SAMPLES WERE UNAVAILABLE FOR RETURN, OUR QUALITY ENGINEER TEAM WAS UNABLE TO COMPLETE A THOROUGH SAMPLE ANALYSIS. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THIS INCIDENT.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: IMDRF ANNEX B GRID: B02. H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2102002. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS SAMPLES WERE UNAVAILABLE FOR RETURN, OUR QUALITY ENGINEER TEAM WAS UNABLE TO COMPLETE A THOROUGH SAMPLE ANALYSIS. TWENTY RETAINED SAMPLES OF THE SAME LOT NUMBER WERE OBTAINED. THE RETAINED SAMPLES WERE ASSEMBLED WITH A BD DISCARDIT SYRINGE AND NO SIGNS OF DEFECTIVE HUB CONNECTION OR LEAKAGE WERE IDENTIFIED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THIS INCIDENT.
IT WAS REPORTED THAT THE 25 G X 1 IN. ECLIPSE NEEDLE SMARTSLIP EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILST ADMINISTERING A SUBCUTANEOUS INJECTION OF BORTEZOMIB (3MG IN 1.2ML) WHEN INCIDENT REPORTER AND THE PATIENT FELT A DRIBBLE NEAR THE INJECTION SITE. THEY REALIZED THAT SOME OF THE MEDICATION HAD LEAKED BETWEEN THE SYRINGE AND NEEDLE. THE NEEDLE CANNOT HAVE BEEN FULLY SCREWED/FITTED INTO THE SYRINGE. IT IS NOT POSSIBLE TO DETERMINE HOW MUCH OF THE 1.2ML LEAKED OUT. THERE HAVE BEEN ISSUES WITH THIS BATCH OF ORANGE NEEDLES BD ECLIPSE WITH SMARTSLIP TECHNOLOGY 25G. WASHED THE PATIENT'S HAND AND STOMACH THOROUGHLY WITH SOAP AND WATER AND RINSED AND DRIED BOTH TOO. BORTEZOMIB IS NEUTRAL AND NOT AN IRRITANT OR VESICANT. EXPLAINED TO THE PATIENT THAT BORTEZOMIB IS NOT A CHEMOTHERAPY AND IS NOT LIKELY TO CAUSE ANY SKIN IRRITATION, BUT IT WAS IMPORTANT TO CLEANSE THE SKIN. I TOLD HIM TO MONITOR HIS SKIN AND STOMACH FOR ANY SIGNS OF IRRITATION AS A PRECAUTION. THE PATIENT ASKED IF THE TREATMENT WOULD NEED RE-DOING. TOLD PATIENT NO AS IT WAS NOT POSSIBLE TO DETERMINE HOW MUCH LEAKED OUT AND WHAT DOSE WAS GIVEN. WE DID NOT WANT TO GIVE TOO MUCH. THE PATIENT WAS DISCHARGED HOME.
IT WAS REPORTED THAT THE 25 G X 1 IN. ECLIPSE NEEDLE SMARTSLIP EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILST ADMINISTERING A SUBCUTANEOUS INJECTION OF BORTEZOMIB (3MG IN 1.2ML) WHEN INCIDENT REPORTER AND THE PATIENT FELT A DRIBBLE NEAR THE INJECTION SITE. THEY REALIZED THAT SOME OF THE MEDICATION HAD LEAKED BETWEEN THE SYRINGE AND NEEDLE. THE NEEDLE CANNOT HAVE BEEN FULLY SCREWED/FITTED INTO THE SYRINGE. IT IS NOT POSSIBLE TO DETERMINE HOW MUCH OF THE 1.2ML LEAKED OUT. THERE HAVE BEEN ISSUES WITH THIS BATCH OF ORANGE NEEDLES BD ECLIPSE WITH SMARTSLIP TECHNOLOGY 25G. WASHED THE PATIENT'S HAND AND STOMACH THOROUGHLY WITH SOAP AND WATER AND RINSED AND DRIED BOTH TOO. BORTEZOMIB IS NEUTRAL AND NOT AN IRRITANT OR VESICANT. EXPLAINED TO THE PATIENT THAT BORTEZOMIB IS NOT A CHEMOTHERAPY AND IS NOT LIKELY TO CAUSE ANY SKIN IRRITATION, BUT IT WAS IMPORTANT TO CLEANSE THE SKIN. I TOLD HIM TO MONITOR HIS SKIN AND STOMACH FOR ANY SIGNS OF IRRITATION AS A PRECAUTION. THE PATIENT ASKED IF THE TREATMENT WOULD NEED RE-DOING. TOLD PATIENT NO AS IT WAS NOT POSSIBLE TO DETERMINE HOW MUCH LEAKED OUT AND WHAT DOSE WAS GIVEN. WE DID NOT WANT TO GIVE TOO MUCH. THE PATIENT WAS DISCHARGED HOME.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER FACILITY NAME: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT THE 25 G X 1 IN. ECLIPSE NEEDLE SMARTSLIP EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILST ADMINISTERING A SUBCUTANEOUS INJECTION OF BORTEZOMIB (3MG IN 1.2ML) WHEN INCIDENT REPORTER AND THE PATIENT FELT A DRIBBLE NEAR THE INJECTION SITE. THEY REALIZED THAT SOME OF THE MEDICATION HAD LEAKED BETWEEN THE SYRINGE AND NEEDLE. THE NEEDLE CANNOT HAVE BEEN FULLY SCREWED/FITTED INTO THE SYRINGE. IT IS NOT POSSIBLE TO DETERMINE HOW MUCH OF THE 1.2ML LEAKED OUT. THERE HAVE BEEN ISSUES WITH THIS BATCH OF ORANGE NEEDLES BD ECLIPSE WITH SMARTSLIP TECHNOLOGY 25G. WASHED THE PATIENT'S HAND AND STOMACH THOROUGHLY WITH SOAP AND WATER AND RINSED AND DRIED BOTH TOO. BORTEZOMIB IS NEUTRAL AND NOT AN IRRITANT OR VESICANT. EXPLAINED TO THE PATIENT THAT BORTEZOMIB IS NOT A CHEMOTHERAPY AND IS NOT LIKELY TO CAUSE ANY SKIN IRRITATION, BUT IT WAS IMPORTANT TO CLEANSE THE SKIN. I TOLD HIM TO MONITOR HIS SKIN AND STOMACH FOR ANY SIGNS OF IRRITATION AS A PRECAUTION. THE PATIENT ASKED IF THE TREATMENT WOULD NEED RE-DOING. TOLD PATIENT NO AS IT WAS NOT POSSIBLE TO DETERMINE HOW MUCH LEAKED OUT AND WHAT DOSE WAS GIVEN. WE DID NOT WANT TO GIVE TOO MUCH. THE PATIENT WAS DISCHARGED HOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1301254 | 25 G X 1 IN. ECLIPSE NEEDLE SMARTSLIP | HYPODERMIC SINGLE LUMEN NEEDLE | FMI | BECTON DICKINSON, S.A. | 305891 | 2102002 | 50382903058919 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |