BD INSULIN SYRINGE W/ BD ULTRA-FINE NEEDLE
Report
- Report Number
- 1920898-2019-00776
- Event Type
- Malfunction
- Date Received
- August 8, 2019
- Date of Event
- July 23, 2019
- Report Date
- August 23, 2019
- Manufacturer
- BD MEDICAL - DIABETES CARE
- Product Code
- FMF
- UDI-DI
- 00382903249107
- PMA / PMN Number
- K024112
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
INVESTIGATION SUMMARY: SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. CUSTOMER RETURNED (100) 3/10CC, 6MM, 31G SYRINGES IN SEALED POLY BAGS WITH THE SHELF CARTON FROM LOT # 9070627. CUSTOMER STATES THAT THERE ARE TWO DIFFERENT PRODUCTS IN THE BOX. ALL OF THE RETURNED POLY BAGS WERE EXAMINED AND 4 OUT OF THE 10 POLY BAGS ARE FROM CAT # 324910, LOT # 9070627. ALL 6 REMAINING POLY BAGS IN THE SHELF CARTON ARE FROM CAT # 324916, LOT # 9098633. THIS IS THE 1ST COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. BD WAS ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE AND BASED ON TREND ANALYSIS NO FURTHER ACTION IS REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. AS PER REQUEST, (10) SAMPLES FROM EACH OF THE DIFFERENT CAT #/LOT # COMBINATIONS WERE TESTED TO DETERMINE IF THE SAMPLES ARE THE CORRECT GAUGE. EACH OF THE CAT #/LOT # COMBINATION STATE THAT THE SAMPLES SHOULD BE 31G (SPECS: OUTER DIAMETER FOR 31G: 0.0100¿-0.0105¿). ALL TESTED SAMPLES FALL WITHIN SPECIFICATIONS FOR 31G, AS STATED ON EACH OF THE POLY BAGS. AS PER INVESTIGATION COMPLETED BY MANUFACTURING, "PROBLEM STATEMENT: CUSTOMER RETURNED A CARTON OF SYRINGES THAT CONTAINED 6 INCORRECT POLYBAGS. THE CARTON IS FOR SKU 324910 BATCH# 9070627 0.3ML 31 X 6MM SYRINGES. THE 6 POLYBAGS INSIDE OF THE CARTON WERE NOT CORRECT, THEY WERE FOR SKU 324916 BATCH# 9098633 0.3ML 31 X 6MM. RECORD REVIEW INCLUDING LINE CLEARANCE & REVIEW OF PRODUCTION DATES: MATERIAL 324910 BATCH 9070627 SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAG WAS RAN ON PACKAGING LINE 0.3ML ON 05 JUN 2019 TO 06 JUN 2019. LINE CLEARANCE WAS COMPLETED AND SIGNED OFF AS COMPLETED ON 05 JUN 2019. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 924910. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. MATERIAL 324916 BATCH 9098633 WAS RAN ON PACKAGING LINE 0.3ML ON 05 JUN 2019. LINE CLEARANCE WAS COMPLETED AND SIGNED OFF ON 05 JUN 2019. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9098633. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. RESULTS OF PRODUCTION EVALUATION THE 6 INCORRECT POLYBAGS FROM SKU 324916 WERE RAN ON 0.3ML PACKAGING LINE DIRECTLY BEFORE SKU 324910. ALL BAGS IN THE CARTON WERE FROM NW FORM FILL AND SEAL PACKAGING MACHINE. POTENTIAL ROOT CAUSE: LACK OF ADHERENCE TO A STANDARD. LACK ON AN ADEQUATE STANDARD. INCOMPLETE LINE CLEARANCE. CORRECTIVE ACTION: THE TIMING ON THE INCLINE CONVEYOR WAS CHANGED SO THAT THE POLYBAGS RUN ALL THE WAY OFF THE CONVEYOR BEFORE IT SHUTS OFF. REFERENCE SA-BDDC-19-1633-SA COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS."
MATERIAL NO: 324910 BATCH NO: 9070627. IT WAS REPORTED THAT BEFORE USE OF THE BD INSULIN SYRINGE W/ BD ULTRA-FINE¿ NEEDLE A TECH OPENED A BOX OF 531-920107 AND FOUND TWO DIFFERENT PRODUCTS INSIDE. THERE WERE FOUR BAGS OF THE CORRECT PRODUCT AND SIX BAGS OF DIFFERENT PRODUCT WITH PORTUGUESE LANGUAGE ON THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A TECH OPENED A BOX OF 531-920107 AND FOUND TWO DIFFERENT PRODUCTS INSIDE. THERE WERE FOUR BAGS OF THE CORRECT PRODUCT (531-920107, 31G 6MM 1/2U, REFERENCE ID 324910) AND SIX BAGS OF A DIFFERENT PRODUCT (NO NDC, 30G 6MM 1/4U, REFERENCE ID 324916). THE LOT ON THE BOX IS 9070627. I'M ASSUMING THIS IS DUE TO A MIX-UP AT THE FACTORY AS ALL THE TEXT ON THE INCORRECT ITEM IS IN PORTUGUESE. I DID GO THROUGH A HANDFUL OF BOXES ON THE SHELF AND THIS IS ONLY MIXED BOX THAT HAS BEEN FOUND SO FAR.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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.
MATERIAL NO: 324910, BATCH NO: 9070627. IT WAS REPORTED THAT BEFORE USE OF THE BD INSULIN SYRINGE W/ BD ULTRA-FINE¿ NEEDLE A TECH OPENED A BOX OF 531-920107 AND FOUND TWO DIFFERENT PRODUCTS INSIDE. THERE WERE FOUR BAGS OF THE CORRECT PRODUCT AND SIX BAGS OF DIFFERENT PRODUCT WITH (B)(6) LANGUAGE ON THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A TECH OPENED A BOX OF 531-920107 AND FOUND TWO DIFFERENT PRODUCTS INSIDE. THERE WERE FOUR BAGS OF THE CORRECT PRODUCT (531-920107, 31G 6 MM 1/2U, REFERENCE ID 324910) AND SIX BAGS OF A DIFFERENT PRODUCT (NO NDC, 30G 6 MM 1/4U, REFERENCE ID 324916). THE LOT ON THE BOX IS 9070627. I'M ASSUMING THIS IS DUE TO A MIX-UP AT THE FACTORY AS ALL THE TEXT ON THE INCORRECT ITEM IS IN PORTUGUESE. I DID GO THROUGH A HANDFUL OF BOXES ON THE SHELF AND THIS IS ONLY MIXED BOX THAT HAS BEEN FOUND SO FAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 669996 | BD INSULIN SYRINGE W/ BD ULTRA-FINE NEEDLE | PISTON SYRINGE | FMF | BD MEDICAL - DIABETES CARE | 9070627 | 00382903249107 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |