BD ULTRA-FINE¿ INSULIN SYRINGE
Report
- Report Number
- 1920898-2018-00240
- Event Type
- Malfunction
- Date Received
- April 11, 2018
- Date of Event
- March 28, 2018
- Report Date
- September 6, 2018
- Manufacturer
- BD MEDICAL - DIABETES CARE
- Product Code
- FMF
- UDI-DI
- 00382903249114
- PMA / PMN Number
- K024112
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PATIENT
Narratives
INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. DEVICE HISTORY RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7226720. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. SYRINGE ASSEMBLY ¿ THERE WAS ONE (1) BATCH OF MATERIAL# 700003992 (SYRINGE 0.5ML ASM 31GA 6MMTW SM700178 SC) THAT WENT INTO THE FINISHED BATCH# 7226720. BATCH# 7262785. DATE(S) OF MANUFACTURE: 27SEP2017 TO 29SEP2017. MACHINE(S) MANUFACTURED ON: JA, JS, JY. BATCH# 7258689. DATE(S) OF MANUFACTURE: 23SEP2017 TO 29SEP2017. MACHINE(S) MANUFACTURED ON: JQ, JT, JV, JS, JU. PRINTERS¿ THERE WERE FIVE (5) BATCHES OF MATERIAL# 700003990 (BARREL 0.5ML PRINTED SM700178) THAT WENT INTO THE FINISHED BATCH# 7226720. BATCH# 7256753. DATE(S) OF MANUFACTURE: 15SEP2017 TO 29SEP2017. MACHINE(S) MANUFACTURED ON: CJ, CV. BATCH# 7256751. DATE(S) OF MANUFACTURE: 17SEP2017 TO 29SEP2017. MACHINE(S) MANUFACTURED ON: CY, CV, CH, CR. BATCH# 7256749. DATE(S) OF MANUFACTURE: 14SEP2017 TO 29SEP2017. MACHINE(S) MANUFACTURED ON: CP. BATCH# 7249699. DATE(S) OF MANUFACTURE: 14SEP2017 TO 29SEP2017. MACHINE(S) MANUFACTURED ON: CS, CR, CH, CY. BATCH# 7244832. DATE(S) OF MANUFACTURE: 08SEP2017 TO 09OCT2017. MACHINE(S) MANUFACTURED ON: CI. THERE WERE SIXTEEN (16) NOTIFICATIONS RELATED TO PRINT DEFECTS: 200710902, 200710703,200710677, 200710881, 200710695, 200710879, 200710694, 200710676, 200710466. 200710811 - MISSING/ SCRATCHED PRINT. 200710157, 200710903, 200710156, 200707728 - MISSING ZERO LINE. 200709006 - BLACK BARRELS. 200709003 - EXCESSIVE INK. THERE WERE SEVENTEEN (17) NOTIFICATIONS [200710630, 200710774, 200710749, 200710760, 200710772, 200712155, 200707729, 200710902, 200711363, 200710629, 200710061, 200709427, 200709844, 200709799, 200710694, 200709831, 200708695] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. NO SAMPLES / PHOTO(S) RECEIVED, THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION.
INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) LOOSE 1/2CC, 6MM SYRINGE WITH PART OF THE SHELF CARTON FROM LOT # 7226720. CUSTOMER STATES THAT THE SYRINGE HAD NO MARKINGS FOR UNITS. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED NO SCALE MARKINGS PRINTED ON THE BARREL. CAPA 162566 WAS INITIATED BY THE HOLDREGE PLANT TO ADDRESS BARREL PRINT ISSUES AND THEIR ASSOCIATED ROOT CAUSE(S). BATCH# 7226720 WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF CORRECTIVE/PREVENTIVE ACTIONS ASSOCIATED WITH THIS CAPA. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7226720. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE SIXTEEN (16) NOTIFICATIONS RELATED TO PRINT DEFECTS: 200710902, 200710703,200710677, 200710881, 200710695, 200710879, 200710694, 200710676, 200710466, 200710811 - MISSING/ SCRATCHED PRINT 200710157, 200710903, 200710156, 200707728 - MISSING ZERO LINE 200709006 - BLACK BARRELS. 200709003 - EXCESSIVE INK. THERE WERE SEVENTEEN (17) NOTIFICATIONS [200710630, 200710774, 200710749, 200710760, 200710772, 200712155, 200707729, 200710902, 200711363, 200710629, 200710061, 200709427, 200709844, 200709799, 200710694, 200709831, 200708695] NOTED THAT DID NOT PERTAIN 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. INVESTIGATION CONCLUSION: POSSIBLE ROOT CAUSES FOR MISSING SCALE MARKINGS INCLUDE: DAMAGE TO THE PAD. PRINT DRUM NOT TOUCHING THE PAD FOR INK TRANSFER. PAD HEAT SET INCORRECTLY. PRINT HEAD TIMING OUT OF ADJUSTMENT. CAPA 162566 WAS INITIATED BY THE HOLDREGE PLANT TO ADDRESS BARREL PRINT ISSUES AND THEIR ASSOCIATED ROOT CAUSE(S). BATCH# 7226720 WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF CORRECTIVE/PREVENTIVE ACTIONS ASSOCIATED WITH THIS CAPA.
IT WAS REPORTED THAT MULTIPLE BD ULTRA-FINE¿ INSULIN SYRINGE(S) WERE MISSING MARKINGS ON THE SYRINGE AND THEREFORE COULD NOT BE USED ACCURATELY FOR INJECTIONS. THE DEVICE WAS NOT USED AND THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6) HAS BEEN USED AS A DEFAULT. A SAMPLE IS NOT AVAILABLE FOR EVALUATION. HOWEVER, A NO SAMPLE INVESTIGATION AND DEVICE HISTORY RECORD REVIEW WILL BE COMPLETED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
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 THAT MULTIPLE BD ULTRA-FINE¿ INSULIN SYRINGE(S) WERE MISSING MARKINGS ON THE SYRINGE AND THEREFORE COULD NOT BE USED ACCURATELY FOR INJECTIONS. THE DEVICE WAS NOT USED AND THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.
IT WAS REPORTED THAT MULTIPLE BD ULTRA-FINE INSULIN SYRINGE(S) WERE MISSING MARKINGS ON THE SYRINGE AND THEREFORE COULD NOT BE USED ACCURATELY FOR INJECTIONS. THE DEVICE WAS NOT USED AND THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 266725 | BD ULTRA-FINE¿ INSULIN SYRINGE | INSULIN SYRINGE | FMF | BD MEDICAL - DIABETES CARE | 7226720 | 00382903249114 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |