BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE
Report
- Report Number
- 2243072-2023-00604
- Event Type
- Malfunction
- Date Received
- April 12, 2023
- Date of Event
- March 27, 2023
- Report Date
- August 3, 2023
- Manufacturer
- BD MEDICAL - DIABETES CARE
- Product Code
- FMF
- PMA / PMN Number
- K212499
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- 003
Narratives
UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES D10: RETURNED TO MANUFACTURER ON: H6: INVESTIGATION SUMMARY A COMPLAINT LOT HISTORY CHECK WAS PERFORMED ON LOT # 2241120 FOR SCALE MARKING DEFECTIVE. THIS IS THE 1ST RELATED COMPLAINT FOR SCALE MARKING DEFECTIVE ON LOT # 2241120. INVESTIGATION SUMMARY: CUSTOMER RETURNED TOTAL OF (150) 0.3ML 31GA 8MM SYRINGES. THE (130) SYRINGES FROM THE LOT# 2241120, TEN IN EACH BAG, I.E. 12 CLOSED AND ONE OPEN POLYBAG AND 20 FROM LOT# 2131604, TEN IN EACH BAG, ONE CLOSED AND ONE OPEN POLYBAG. IT WAS REPORTED BY THE CONSUMER THAT FAULTY PRODUCT - INSULIN SYRINGES WITH INCORRECT HAS MARKS RESULTING IN INSULIN OVERDOSE. ALL THE RETURNED SYRINGES WERE VISUALLY EXAMINED AND NO DAMAGES WERE OBSERVED. FOR LOT# 2241120: THE (30) RETURNED SYRINGE WERE VISUALLY EXAMINED AND OBSERVED NO ISSUES. THE SYRINGE WAS INSPECTED VIA GAUGE TO ENSURE CORRECT PLACEMENT OF THE GRADUATION MARKINGS AND OBSERVED THE RETURN SAMPLES FOUND TO BE WITHIN PERMITTED SPECIFICATIONS. FUNCTIONALITY TEST WAS PERFORMED AND OBSERVED NO ISSUES. NO DAMAGE TO THE NEEDLES OF ANY KIND WAS OBSERVED AND ALL FUNCTIONED AS INTENDED. HENCE, THE REPORTED ISSUE COULD NOT BE CONFIRMED BASED ON THE SAMPLES RETURN FOR INVESTIGATION. FOR LOT# 2131604: THE (30) RETURNED SYRINGE WERE VISUALLY EXAMINED AND OBSERVED NO ISSUES. THE SYRINGE WAS INSPECTED VIA GAUGE TO ENSURE CORRECT PLACEMENT OF THE GRADUATION MARKINGS AND OBSERVED ONE OF THE RETURNED SAMPLE FOUND TO BE OUT OF THE PERMITTED SPECIFICATIONS AT THE LEADING EDGE OF 5 UNITS. FUNCTIONALITY TEST WAS PERFORMED AND OBSERVED NO ISSUES. MANUFACTURING HOLDREGE WILL BE NOTIFIED FOR THE SCALE MARKING ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 2241120. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. CONFIRMED: BASED ON THE RETURN SAMPLES, EMBECTA WAS NOT ABLE TO CONFIRM THE CUSTOMER INDICATED ISSUE. ROOT CAUSE CANNOT BE DETERMINED AS THE ISSUE IS UNCONFIRMED. 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.
THE CUSTOMER PROVIDED ADDITIONAL INFORMATION. THE FOLLOWING FIELDS HAVE BEEN UPDATED: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE SCALE MARKINGS WERE INCORRECT AND RESULTED IN AN INSULIN OVERDOSE. THIS OCCURRED WITH AN UNSPECIFIED NUMBER OF SYRINGES IN LOTS 2241120 AND 2131604. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I NEED TO REPORT A FAULTY PRODUCT - INSULIN SYRINGES WITH INCORRECT HAS MARKS RESULTING IN INSULIN OVERDOSE... THIS CONSUMER FEELS MISDOSED BUT DID NOT NEED MEDICAL INTERVENTION. SHE USES A CGM FOR TESTING BLOOD SUGARS AND WAS NOTICING THE READING WERE A LITTLE LOW FOR A FEW WEEKS... CONSUMER REPORTED - THE MARKINGS ARE NOT CONSISTANT. THEY AT TIMES START NOT AT THE ZERO MARKING SPOT. CALLER TAKES 3UNITS OF INSULIN OR LESS 10XS A DAY. VERY SENSITIVE WITH EVEN A 1/2 UNIT. FINDING THE MISSED MARKED SYRINGES THROWS OFF HER CONTINUOUS GLUCOSE TESTINGS. NO MEDICAL ATTENTION HAS BEEN RECEIVED FROM THIS INCIDENT.". D.1. MEDICAL DEVICE BRAND NAME: BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE. D.3. MEDICAL DEVICE CATALOG #: 328440. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 2241120. D.4. MEDICAL DEVICE EXPIRATION DATE: 30-SEP-2027. H.4. DEVICE MANUFACTURE DATE: 29-AUG-2022. D.4. MEDICAL DEVICE LOT #: 2131604. D.4. MEDICAL DEVICE EXPIRATION DATE: 30-APR-2027. H.4. DEVICE MANUFACTURE DATE: 11-MAY-2022. D.5. MEDICAL DEVICE MANUFACTURER: BD MEDICAL - DIABETES CARE. D.6. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.3. MANUFACTURING LOCATION: BD MEDICAL - DIABETES CARE. G.5. PMA / 510(K)#: K212499.
IT WAS REPORTED THAT THE UNSPECIFIED BD¿ INSULIN SYRINGE SCALE MARKINGS WERE INCORRECT AND RESULTED IN AN INSULIN OVERDOSE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I NEED TO REPORT A FAULTY PRODUCT - INSULIN SYRINGES WITH INCORRECT HAS MARKS RESULTING IN INSULIN OVERDOSE."
IT WAS REPORTED THAT THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE SCALE MARKINGS WERE INCORRECT AND RESULTED IN AN INSULIN OVERDOSE. THIS OCCURRED WITH AN UNSPECIFIED NUMBER OF SYRINGES IN LOTS 2241120 AND 2131604. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I NEED TO REPORT A FAULTY PRODUCT - INSULIN SYRINGES WITH INCORRECT HAS MARKS RESULTING IN INSULIN OVERDOSE... THIS CONSUMER FEELS MISDOSED BUT DID NOT NEED MEDICAL INTERVENTION. SHE USES A CGM FOR TESTING BLOOD SUGARS AND WAS NOTICING THE READING WERE A LITTLE LOW FOR A FEW WEEKS... CONSUMER REPORTED - THE MARKINGS ARE NOT CONSISTANT. THEY AT TIMES START NOT AT THE ZERO MARKING SPOT. CALLER TAKES 3UNITS OF INSULIN OR LESS 10XS A DAY. VERY SENSITIVE WITH EVEN A 1/2 UNIT. FINDING THE MISSED MARKED SYRINGES THROWS OFF HER CONTINUOUS GLUCOSE TESTINGS. NO MEDICAL ATTENTION HAS BEEN RECEIVED FROM THIS INCIDENT."
IT WAS REPORTED THAT THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE SCALE MARKINGS WERE INCORRECT AND RESULTED IN AN INSULIN OVERDOSE. THIS OCCURRED WITH AN UNSPECIFIED NUMBER OF SYRINGES IN LOTS 2241120 AND 2131604. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I NEED TO REPORT A FAULTY PRODUCT - INSULIN SYRINGES WITH INCORRECT HAS MARKS RESULTING IN INSULIN OVERDOSE... THIS CONSUMER FEELS MISDOSED BUT DID NOT NEED MEDICAL INTERVENTION. SHE USES A CGM FOR TESTING BLOOD SUGARS AND WAS NOTICING THE READING WERE A LITTLE LOW FOR A FEW WEEKS... CONSUMER REPORTED - THE MARKINGS ARE NOT CONSISTANT. THEY AT TIMES START NOT AT THE ZERO MARKING SPOT. CALLER TAKES 3UNITS OF INSULIN OR LESS 10XS A DAY. VERY SENSITIVE WITH EVEN A 1/2 UNIT. FINDING THE MISSED MARKED SYRINGES THROWS OFF HER CONTINUOUS GLUCOSE TESTINGS. NO MEDICAL ATTENTION HAS BEEN RECEIVED FROM THIS INCIDENT.".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 992095 | BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE | PISTON SYRINGE | FMF | BD MEDICAL - DIABETES CARE | SEE H10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |