BD MICRO-FINE¿ INSULIN SYRINGE WITH NEEDLE
Report
- Report Number
- 1920898-2018-00470
- Event Type
- Malfunction
- Date Received
- July 6, 2018
- Date of Event
- May 31, 2018
- Report Date
- August 14, 2018
- Manufacturer
- BD MEDICAL - DIABETES CARE
- Product Code
- FMF
- PMA / PMN Number
- K010890
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
CORRECTION: 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 MANUFACTURER: YES.
INVESTIGATION SUMMARY: SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 2ND RELATED COMPLAINT REPORTED FOR THE DEFECT/CONDITION ON LOT NUMBER: 7142856, THIS IS THE 1ST RELATED COMPLAINT REPORTED FOR THE DEFECT/CONDITION ON LOT NUMBER: 7205931, THIS IS THE 3RD RELATED COMPLAINT REPORTED FOR THE DEFECT/CONDITION ON LOT NUMBER: 7086628, THIS IS THE 4TH RELATED COMPLAINT REPORTED FOR THE DEFECT/CONDITION ON LOT NUMBER: 6326899, THIS IS THE 2ND RELATED COMPLAINT REPORTED FOR THE DEFECT/CONDITION ON LOT NUMBER: 6195895, THIS IS THE 2ND RELATED COMPLAINT REPORTED FOR THE DEFECT/CONDITION ON LOT NUMBER: 3231095, THIS IS THE 3RD RELATED COMPLAINT REPORTED FOR THE DEFECT/CONDITION ON LOT NUMBER: 7010764, AND THIS IS THE 1ST RELATED COMPLAINT REPORTED FOR THE DEFECT/CONDITION ON LOT NUMBER: 7254506. CUSTOMER RETURNED TO FRANKLIN LAKES, (3) 1/2CC, 8MM, 30G SYRINGES IN AN OPEN POLY BAG FROM LOT#: 7086628, (3) 1/2CC, 8MM, 30G SYRINGES IN AN OPEN POLY BAG FROM LOT#: 7205931, (3) 1/2CC, 8MM, 30G SYRINGES IN AN OPEN POLY BAG FROM LOT#: 7254506, AND (3) 1/2CC, 8MM, 30G SYRINGES IN AN OPEN POLY BAG FROM LOT#: 7142856. NO SAMPLES WERE RECEIVED FROM LOT#: 6326899, 6195895, 3231095, OR 7010764. CUSTOMER STATES THAT MANY SYRINGES HAVE EXCESS SILICONE OIL THAT CAN ENTER INTO THE BODY DURING INJECTION. ALL RETURNED SYRINGES WERE EXAMINED UNDER THE MICROSCOPE AND (2) SAMPLES FROM LOT#: 7205931 AND (1) SAMPLES FROM LOT#: 7254506 EXHIBITED A VERY SMALL BUT VISIBLE AMOUNT OF CLEAR LIQUID IN THE BARREL. NO VISIBLE LIQUID OR ANY OTHER FOREIGN MATTER WAS OBSERVED IN ANY OF THE OTHER SYRINGES. A SMALL AMOUNT OF THE CLEAR LIQUID OBSERVED IN SAMPLES FROM LOT#: 7205931 AND 7254506 WAS REMOVED FROM THE SAMPLES AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SHOWS THAT THE CLEAR LIQUID IN SAMPLES FROM BOTH OF THE LOT NUMBERS IN QUESTION IS MOST LIKELY SILICONE. SILICONE IS AN INERT, NON-TOXIC MEDICAL SUBSTANCE USED AS A LUBRICANT FOR DISPOSABLE HYPODERMIC PRODUCTS. IT IS AN INTEGRAL PART OF THE SYRINGE, ENABLING IT TO PERFORM AS REQUIRED IN VARIOUS CLINICAL APPLICATIONS AND DOES NOT PRESENT A SAFETY OR EFFICACY ISSUE NOR DOES IT IMPACT PRODUCT FUNCTION. THE SILICONE APPLICATION PROCESS IS DESIGNED TO PROVIDE AN EVEN DISTRIBUTION OF SILICONE ON THE INTERIOR OF THE SYRINGE BARREL. WHEN THE PLUNGER IS FULLY DEPRESSED, THE SILICONE GETS DISTRIBUTED ALONG THE BARREL ROOF AND WALLS, ENSURING A LUBRICATED SURFACE FOR THE PLUNGER TO MOVE AGAINST. SILICONE HAS BEEN IN USE IN THIS APPLICATION FOR OVER 20 YEARS, WITH ESTIMATED DISTRIBUTION WELL IN EXCESS OF (B)(4) UNITS. NO REPORTS ARE KNOWN OF ADVERSE CLINICAL EFFECTS ASSOCIATED WITH THESE PRODUCTS AND UNINTENTIONAL DELIVERY OF SILICONE FLUID LUBRICANT. SAMPLES WERE FORWARDED TO MANUFACTURING (HOLDREGE) ON 20JUL2018 FOR FURTHER REVIEW. ON 26JUL2018, HOLDREGE RECEIVED THE FOLLOWING SAMPLES FOR THIS RECORD: THREE (3) 0.5ML, 8MM, 30G SYRINGES IN AN OPEN POLY BAG FROM LOT#: 7086628, THREE (3) 0.5ML, 8MM, 30G SYRINGES IN AN OPEN POLY BAG FROM LOT#: 7205931, THREE (3) 0.5ML, 8MM, 30G SYRINGES IN AN OPEN POLY BAG FROM LOT#: 7254506, AND THREE (3) 0.5ML, 8MM, 30G SYRINGES IN AN OPEN POLY BAG FROM LOT #: 7142856. NO SAMPLES WERE RECEIVED FROM LOT#: 6326899, 6195895, 3231095, OR 7010764. ALL SAMPLES WERE DECONTAMINATED PER HSTR-17 PRIOR TO BEING EVALUATED. UPON EVALUATION BY QE AH, SIMILAR FINDINGS TO THOSE DOCUMENTED DURING INITIAL INVESTIGATION PERFORMED AT BD FRANKLIN LAKES WERE NOTED. NO VISIBLE LIQUID WAS NOTED WITHIN THE RECEIVED SAMPLES. PER FTIR ANALYSIS, FLUID NOTED IN INITIAL INVESTIGATION IS MOST LIKELY SILICONE. SILICONE IS USED WITHIN THE SYRINGE BARREL TO ALLOW FOR A SMOOTHER GLIDE DURING ASPIRATION AND INJECTION OF MEDICATION. THE SILICONE USED IN THE MANUFACTURING PROCESS IS OF MEDICAL GRADE AND SELECTED DUE TO ITS INERT PROPERTIES. WHEN UTILIZED FOR THE INSULIN SYRINGE IS USED AS DIRECTED AND FOR THE INTENDED USE, THE SILICONE SHOULD CONFER NO NOTABLE IMPACT TO THE RECIPIENT OF AN INJECTION. CAPA: 56537 AND SA BDDC-16-871-SA WERE COMPLETED TO ADDRESS EXCESS SILICONE AND ITS ASSOCIATED ROOT CAUSE(S). A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH#: 7205931. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE FOUR (4) NOTIFICATIONS [200707790, 200707911, 200707894, 200707995] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH#: 7086628. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ELEVEN (11) NOTIFICATIONS [200692523, 200692288, 200692415, 200692421, 200692524, 200692373, 200692392, 200692432, 200692061, 200689659, 200690103] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH#: 6326899. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200675593, 200675561] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH#: 6195895. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH#: 3231095. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [126307] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH#: 7010764. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE NO NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH#: 7254506. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (FOR LOT#: 7205931 AND 7254506). UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (FOR LOT#: 7142856, 7086628 6326899, 6195895, 3231095, OR 7010764). 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.
IT WAS REPORTED THAT EXCESS SILICONE OIL WAS FOUND IN SEVERAL BD MICRO-FINE¿ INSULIN SYRINGE(S) WITH NEEDLE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.
IT WAS REPORTED THAT EXCESS SILICONE OIL WAS FOUND IN SEVERAL BD MICRO-FINE¿ INSULIN SYRINGE(S) WITH NEEDLE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.
THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7142856; MEDICAL DEVICE EXPIRATION DATE: 2022-06-30; DEVICE MANUFACTURE DATE: 2017-05-22; MEDICAL DEVICE LOT #: 7205931; MEDICAL DEVICE EXPIRATION DATE: 2022-07-31; DEVICE MANUFACTURE DATE: 2017-07-24; MEDICAL DEVICE LOT #: 7086628; MEDICAL DEVICE EXPIRATION DATE: 2022-04-30; DEVICE MANUFACTURE DATE: 2017-03-27; MEDICAL DEVICE LOT #: 6326899; MEDICAL DEVICE EXPIRATION DATE: 2021-12-31; DEVICE MANUFACTURE DATE: 2016-11-21; MEDICAL DEVICE LOT #: 6195895; MEDICAL DEVICE EXPIRATION DATE: 2021-07-31; DEVICE MANUFACTURE DATE: 2016-07-13; MEDICAL DEVICE LOT #: 3231095; MEDICAL DEVICE EXPIRATION DATE: 2018-08-31; DEVICE MANUFACTURE DATE: 2013-08-19; MEDICAL DEVICE LOT #: 7010764; MEDICAL DEVICE EXPIRATION DATE: 2022-01-31; DEVICE MANUFACTURE DATE: 2017-01-10; MEDICAL DEVICE LOT #: 7254506; MEDICAL DEVICE EXPIRATION DATE: 2022-09-30; DEVICE MANUFACTURE DATE: 2017-09-11. 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.
IT WAS REPORTED THAT EXCESS SILICONE OIL WAS FOUND IN SEVERAL BD MICRO-FINE¿ INSULIN SYRINGE(S) WITH NEEDLE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 510246 | BD MICRO-FINE¿ INSULIN SYRINGE WITH NEEDLE | INSULIN SYRINGE | FMF | BD MEDICAL - DIABETES CARE | SEE H.10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |