NEEDLE 19X1-1/2 RB TW
Report
- Report Number
- 1911916-2019-01047
- Event Type
- Malfunction
- Date Received
- October 4, 2019
- Date of Event
- September 18, 2019
- Report Date
- November 20, 2019
- Manufacturer
- BD MEDICAL (BD WEST) MEDICAL SURGICAL
- Product Code
- FMI
- UDI-DI
- 30382903051879
- PMA / PMN Number
- K021475
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
H.6. INVESTIGATION: APPROXIMATELY ONE THOUSAND FOUR HUNDRED (1,400) SAMPLES WERE PROVIDED BY THE CUSTOMER FOR INVESTIGATION WITH TWO HUNDRED (200) SAMPLES BEING FROM BATCH # 8250805, THREE HUNDRED (300) SAMPLES BEING FROM BATCH # 8292593 AND NINE HUNDRED (900) SAMPLES BEING FROM BATCH # 9030812. THE RETURNED SAMPLES WERE RETURNED IN UNOPENED BLISTER PACKS AND SHELF CARTONS. THE TWO HUNDRED (200) SAMPLES FROM BATCH # 8250805 WERE VISUALLY EXAMINED USING UNAIDED VISION WITH NO MIXED PRODUCT BEING OBSERVED. THE THREE HUNDRED (300) SAMPLES FROM BATCH # 8292593 WERE VISUALLY EXAMINED USING UNAIDED VISION WITH NO MIXED PRODUCT BEING OBSERVED. TWO HUNDRED (200) SAMPLES FROM BATCH # 9030812 WERE VISUALLY EXAMINED AND IT WAS OBSERVED THAT THERE WERE NEEDLE ASSEMBLIES WITH THE INCORRECT NEEDLE HUB AND NEEDLE MIXED IN WITH THE CORRECT NEEDLE ASSEMBLIES. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE BATCHES ASSOCIATED WITH THIS INVESTIGATION. THE DHR REVIEWS DID NOT REVEAL ANY DEFECTS OR ISSUES REPORTED AND NO QUALITY NOTIFICATIONS WERE ISSUED. HOWEVER, DURING THE INVESTIGATION IT WAS OBSERVED THAT A LOT #8150902 OF MATERIAL #8020473 (NEEDLE 22 GA 1-1/4IN) WAS BEING PRODUCED AT THE SAME TIME AS LOT #9031984 OF MATERIAL # 50815 (NEEDLE 19GA 1-1/2IN) ON TWO (2) NEEDLE IN PROCESS (NIP) LINES WHICH WERE LOCATED NEXT TO EACH OTHER WITH BATCH # 50815 BEING PACKAGED IN BATCH # 9030812. THEREFORE, IT IS LIKELY THAT ONE (1) BAG OF LOT #8020473 OF MATERIAL #8020473 (NEEDLE 22 GA 1-1/4IN) FROM NIP 5 WAS PLACED IN THE GAYLORD FOR LOT #9031984 OF MATERIAL # 50815 (NEEDLE 19GA 1-1/2IN). THIS GAYLORD WAS THEN PACKAGED ON MULTI VAC 4 (MV 4) IN BATCH # 9030812 WITH THE MIXED PRODUCT GETTING PACKAGED WITHOUT BEING NOTICED. ON 31-OCT-2019 A GLOBAL HOLD WAS ISSUED TO MATERIAL # 305187 LOT #9030812 TO CONTAIN THIS BATCH. AS NO MIXED PRODUCT WAS OBSERVED IN BATCHES # 8250805 AND 8292593 NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE PROPOSED FOR THOSE BATCHES IN THE SCOPE OF THIS COMPLAINT. H3 OTHER TEXT : SEE H.10.
MATERIAL NO: 305187; BATCH NO: 9030812, 8250805 & 8292593. IT WAS REPORTED THAT BEFORE USE OF THE NEEDLE 19X1-1/2 RB TW THE PACKAGE WAS MIXED WITH NEEDLES OF DIFFERENT SIZES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLES ARE ODD SIZES.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9030812; EXPIRATION DATE: 2024-03-31; MANUFACTURE DATE: 2019-01-30. . MEDICAL DEVICE LOT #: 8250805; EXPIRATION DATE: 2023-11-30; MANUFACTURE DATE: 2018-09-07. MEDICAL DEVICE LOT #: 8292593; EXPIRATION DATE: 2023-12-31; MANUFACTURE DATE: 2018-10-19. 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: 305187 BATCH NO: 9030812, 8250805 & 8292593. IT WAS REPORTED THAT BEFORE USE OF THE NEEDLE 19X1-1/2 RB TW THE PACKAGE WAS MIXED WITH NEEDLES OF DIFFERENT SIZES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLES ARE ODD SIZES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 948708 | NEEDLE 19X1-1/2 RB TW | HYPODERMIC SINGLE LUMEN NEEDLE | FMI | BD MEDICAL (BD WEST) MEDICAL SURGICAL | SEE H.10 | 30382903051879 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |