BD SAFETYGLIDE¿ INSULIN SYRINGE WITH ATTACHED NEEDLE
Report
- Report Number
- 1920898-2018-00534
- Event Type
- Malfunction
- Date Received
- July 10, 2018
- Date of Event
- June 13, 2018
- Report Date
- August 16, 2018
- Manufacturer
- BD MEDICAL - DIABETES CARE
- Product Code
- MEG
- PMA / PMN Number
- K992734
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER
Narratives
INVESTIGATION SUMMARY: CUSTOMER RETURNED (8) 1/2ML, 13MM, 29G BD SAFETYGLIDE INSULIN SYRINGES IN OPEN BLISTER PACKS FROM LOT # 8002688 TO FRANKLIN LAKES. CUSTOMER STATES THAT THE ITEMS WERE NOT SEALED IN THE PACKAGING. ALL RETURNED SYRINGES WERE EXAMINED AND ALL EXHIBITED A MISALIGNED CUT OF THE BLISTER PACK CAUSING THE BLISTER PACK TO BE OPEN AND NOT HAVE A PROPER SEAL. SAMPLES WERE FORWARDED TO MANUFACTURING (HOLDREGE) ON 20JUL2018 FOR FURTHER REVIEW. ON 26JUL2018, HOLDREGE RECEIVED EIGHT (8) 0.5ML, 13MM, 29G BD SAFETYGLIDE SYRINGES IN OPEN BLISTERPACKS FROM BATCH# 8002688. ALL SAMPLES WERE DECONTAMINATED PER HSTR-17 PRIOR TO BEING EVALUATED. UPON EVALUATION BY QUALITY ENGINEER AH AND ENGINEERING TECHNICIAN DB, SIMILAR FINDINGS TO THOSE DOCUMENTED DURING INITIAL INVESTIGATION PERFORMED AT BD FRANKLIN LAKES WERE NOTED. VISUAL INSPECTION OF THE RETURNED SAMPLES NOTED THAT EACH INDIVIDUAL BLISTERPACK EXHIBITED ONE (1) EDGE IN WHICH THE TOP AND BOTTOM WEB DID NOT ALIGN CORRECTLY DURING SEALING/CUTTING. TOP AND BOTTOM WEB ARE THE MATERIALS UTILIZED TO CREATE THE BLISTERPACK ITSELF. THE TOP WEB IS THE PAPER-LIKE MATERIAL WHICH CARRIES THE PRODUCT INFORMATION PRE-PRINTED ON IT, AS WELL AS THE INDIVIDUAL LOT CODING (BATCH# AND EXPIRY DATING). THE BOTTOM WEB IS THE TRANSLUCENT MATERIAL IN WHICH THE SYRINGE RESIDES AND THE MATERIAL WHICH IS USUALLY SEALED TO THE TOP WEB AS A STERILITY BARRIER. AS BLISTERPACKS ARE FORMED, A UNIQUE IDENTIFIER IS UTILIZED, IN THIS CASE ALPHABETIC LETTERS, FOR INTERNAL TRACEABILITY PURPOSES; THIS LETTER IDENTIFIER REPRESENTS THE POSITION OF THE INDIVIDUAL BLISTERPACKS AS THEY MOVE THROUGH THE SPECIFIC PACKAGING EQUIPMENT. ALL SAMPLES WHICH WERE RETURNED WERE NOTED TO HAVE COME FROM POSITION "K" ALONG THE PRODUCT CONVEYANCE PATHWAY. THE LETTER "K" REPRESENTS AN END POSITION ON THE CONVEYANCE PATHWAY. THIS COUPLED WITH THE NON-UNIFORM CUTTING AND OVERHANG PATTERN MENTIONED ABOVE, INDICATES THAT PROBABLE ROOT CAUSE WAS A DRAG IN THE TOP WEB, WHICH RESULTED IN INCOMPLETE SEALING DURING PRODUCTION. THIS CAN BE DUE TO A SPLICE OF TOP WEB MATERIAL FROM THE SUPPLIER OR A CATCH POINT IN THE ADVANCEMENT OF THE TOP WEB DURING THE MANUFACTURING PROCESS. THE MACHINERY SELF-CORRECTS AFTER A CERTAIN PERIOD OF TIME, HOWEVER, THE MIS-FORMED BLISTERPACKS MAY GO UNDETECTED AND LATER BE FOUND BY THE CONSUMER. AS THIS TYPE OF EVENT IS TRANSIENT AND WOULD BE CORRECTED WITHOUT OPERATOR INTERVENTION, NO ADDITIONAL INFORMATION OR ACTIONS ARE DEEMED NECESSARY AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8002688. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR OPEN PACKAGE / SEAL ON LOT # 8002688. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: - CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. BASED ON THE ABOVE, NO CAPA IS REQUIRED AT THIS TIME. 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.
CORRECTION: DUE TO AN IT ISSUE BEGINNING ON (B)(6) 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.
IT WAS REPORTED WITH THE USE OF THE BD SAFETYGLIDE¿ INSULIN SYRINGE WITH ATTACHED NEEDLE THERE WAS AN ISSUE WITH STERILE BREACH. IT WAS STATED BY THE CONSUMER ¿THAT WHEN THE CUSTOMER OPENED THE BOX, ABOUT 10 OF THE ITEMS WERE NOT SEALED IN THE PACKAGING.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.
IT WAS REPORTED WITH THE USE OF THE BD SAFETYGLIDE¿ INSULIN SYRINGE WITH ATTACHED NEEDLE THERE WAS AN ISSUE WITH STERILE BREACH. IT WAS STATED BY THE CONSUMER ¿THAT WHEN THE CUSTOMER OPENED THE BOX, ABOUT 10 OF THE ITEMS WERE NOT SEALED IN THE PACKAGING.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.
DATE OF EVENT: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED WITH THE USE OF THE BD SAFETYGLIDE¿ INSULIN SYRINGE WITH ATTACHED NEEDLE THERE WAS AN ISSUE WITH STERILE BREACH. IT WAS STATED BY THE CONSUMER ¿THAT WHEN THE CUSTOMER OPENED THE BOX, ABOUT 10 OF THE ITEMS WERE NOT SEALED IN THE PACKAGING.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 518310 | BD SAFETYGLIDE¿ INSULIN SYRINGE WITH ATTACHED NEEDLE | SAFETY ENGINEERED SYRINGE AND NEEDLE | MEG | BD MEDICAL - DIABETES CARE | 8002688 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |