BD¿ SYRINGE
Report
- Report Number
- 2243072-2018-00468
- Event Type
- Malfunction
- Date Received
- July 16, 2018
- Date of Event
- June 18, 2018
- Report Date
- August 21, 2018
- Manufacturer
- BECTON DICKINSON
- Product Code
- FMF
- PMA / PMN Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER
Narratives
26 SAMPLE WERE RETURNED TO SBDM, THE COMPLAINT LOT NUMBER IS 1803234. RETURNED SAMPLES WERE TESTED FOR LEAKAGE: SBDM CONDUCTED LEAKAGE TEST USING 6 PCS RETURNED SAMPLES AND RESULTS ARE: SYRINGE LEAK TEST: WHEN PULLED STRAIGHT, THE SYRINGES SHOW NO LEAKAGE OR AIR ASPIRATION. WHEN PULLED OBLIQUELY, 4 OF THE SYRINGES SHOW SIGNS OF AIR ASPIRATION. NEEDLE LEAK TEST: WHEN PULLED STRAIGHT, THE NEEDLES SHOW NO LEAKAGE. WHEN PULLED OBLIQUELY, THE NEEDLES SHOW NO LEAKAGE. HOWEVER, AIR ASPIRATION OR LEAKAGE CAN OCCUR DUE TO PULLING DIRECTION OF PLUNGER AS BELOW AS DEMONSTRATED BY SBDM: USER PULLS PLUNGER IN A STRAIGHT MANNER, NO AIR ASPIRATION OR LEAKAGE CAN BE OBSERVED USER PULLS PLUNGER IN OBLIQUELY DIRECTION, AIR ASPIRATION AND LEAKAGE CAN BE OBSERVED DIMENSION MEASUREMENT: FOR THE 6 PCS RETURNED SAMPLES, SBDM MEASURED THE INTERNAL DIAMETER OF BARREL AND OUTER DIAMETER OF STOPPER. THE RESULTS SHOWS THE DIMENSION ARE WITHIN SPECIFICATIONS. BARREL INTERNAL DIAMETER: SPEC F20.05 +/- 0.05MM. SAMPLES WERE MEASURED AT F20.014, F20.055, F20.098, F20.087, F20.026, F20.088. STOPPER OUTER DIAMETER: SPEC F21.0 + 0.05MM. SAMPLES WERE MEASURED AT F21.048, F21.024, F21.028, F21.022, F21.038, F21.021. DEVICE HISTORY RECORD REVIEW: SBDM REVIEWED THE MANUFACTURING RECORDS FOR LOT 1803234. NO ABNORMALITY WAS OBSERVED. CUSTOMER COMPLAINT REVIEW: SBDM REVIEWED INTERNAL COMPLAINT RECORD FOR SAME SKU, THERE WERE SIMILAR ISSUES FROM OTHER CUSTOMERS. ROOT CAUSE: FROM INVESTIGATIONS, SBDM CONSIDERED THE LIKELY CAUSE FOR THE LEAKAGE TO BE INJECTION WORKING CONDITION. SBDM INVESTIGATED THAT THE MEDICINE HOLDING LINE BETWEEN STOPPER AND BARREL OF 20ML SYRINGE IS REDUCED WHEN THE PLUNGER IS PULLED OBLIQUELY, EVEN AS BOTH STOPPER OUTER DIAMETER AND BARREL INNER DIAMETER ARE WITHIN SPECIFICATION. THIS IS DUE TO THE INTERFERENCE FIT BETWEEN STOPPER AND BARREL OF 20ML SYRINGE IS LESSER THAN OTHER SIZE SYRINGES. THE INTERFERENCE FIT OF 10ML(F1), 30ML(F1.35), 50ML(F1) SYRINGE IS MORE THAN F1.0 BUT THE INTERFERENCE FIT OF 20ML SYRINGE IS F0.95). THIS MAY BE ATTRIBUTE TO MOLDED STOP SENSITIVE TO CHANGING OF INJECTION WORKING PARAMETERS, AND IT WILL AFFECT THE INTERFERENCE FIT OF THE STOPPER AND BARREL. THE IDEAL STATE WOULD BE TO ACHIEVE A HIGH MEDICINE HOLDING STRENGTH, IN WHICH THE OUTER DIAMETER OF STOPPER IS BIGGER THAN INNER DIAMETER OF BARREL (MAXIMUM TOLERANCE ALLOWANCE BASED ON SPECIFICATION). SBDM HAS CHANGED RAW MATERIAL SUPPLIER FOR STOPPER DUE TO DISCONTINUITY BY CURRENT SUPPLIER (EXXONMOBIL) SINCE NOV 2017. SBDM QUALIFIED ALTERNATIVE MATERIAL BY ANOTHER SUPPLIER (KUMHO), CONDUCTED VALIDATION INCLUDING LEAKAGE, MOVING FORCE, DEAD SPACE, EXTRACTABLE TEST AND ASSEMBLY TEST. THE VALIDATION WERE COMPLETED NOV 2017, AND VALIDATION RESULTS WERE ACCEPTABLE. SBDM STARTED MASS PRODUCTION SINCE FEB 2018 WITH ALTERNATIVE MATERIAL. FROM THE COMPLAINTS ON SYRINGE LEAKAGE/AIR ASPIRATION, SBDM DISCOVERED THE CUSTOMERS ARE NOT USING THE SYRINGE SAME AS THEIR LEAKAGE TEST METHOD (MOVING A PLUNGER STRAIGHTLY BY TESTING MACHINE). SO, SBDM WILL ENHANCED LEAKAGE TEST METHOD TO ALIGN WITH CUSTOMER`S USING CONDITION. FINALLY, SBDM HAS CONDUCTED A RE-VALIDATION OF INJECTION PROCESS AND CONCLUDED THE OPTIMAL STOPPER INJECTION CONDITION HAD CHANGED DURING MASS PRODUCTION AS COMPARED TO THE CONDITION ACHIEVED WITH VALIDATION PRIOR TO MASS PRODUCTION. SBDM WILL CONTINUED TO MANUFACTURE THE STOPPER USING THE NEW OPTIMAL INJECTION CONDITION ACHIEVED THROUGH RE-VALIDATION CORRECTIVE ACTIONS: 1. SBDM HAD QUALITY TRAINING ON THE CUSTOMER COMPLAINT FOR STOPPER INSPECTION WORKERS AND QUALITY CONTROL WORKER. 2. SBDM STRENGTH INSPECTION FOR 20ML STOPPER AND MONITOR THE LEAKAGE OF THE 20ML SYRINGE FOR EVERY LOT NO. BY ENHANCING INSPECTION METHOD (SIMILAR WITH CUSTOMER¿S USING CONDITION).. 3. SBDM ARE CHECKING AND RECONFIRMING OF INJECTION WORK CONDITION AND IMPLEMENTING OF PREVENTIVE MAINTENANCE FOR GASKET MOLD. 4. SBDM CONDUCTED RE-VALIDATION OF INJECTION PROCESS FOR STOPPER, WHEN IT IS COMPLETED, MANUFACTURED TEST SAMPLES OF 20ML SYRINGE (36,000EA) AND GET CONFIRMATION THAT THERE WAS NO ISSUE FROM BD KOREA.
DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURE: NO.
IT WAS REPORTED THAT THE BD¿ SYRINGE HAD ¿LEAKAGE BETWEEN BARREL AND PLUNGER¿ THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.
IT WAS REPORTED THAT THE BD¿ SYRINGE HAD ¿LEAKAGE BETWEEN BARREL AND PLUNGER¿ THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.
THE MANUFACTURING LOCATION FOR THIS PRODUCT IS SEOUL. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. INITIAL REPORTER PHONE#: (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 BD¿ SYRINGE HAD ¿LEAKAGE BETWEEN BARREL AND PLUNGER¿ THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 531182 | BD¿ SYRINGE | SYRINGE | FMF | BECTON DICKINSON | 1803234 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |