ALARIS SMARTSITE
Report
- Report Number
- 9616066-2025-00357
- Event Type
- Malfunction
- Date Received
- February 27, 2025
- Date of Event
- December 20, 2024
- Report Date
- June 25, 2025
- Manufacturer
- SISTEMAS MEDICOS ALARIS S.A. DE C.V.
- Product Code
- LHI
- UDI-DI
- 07613203011792
- PMA / PMN Number
- K233021
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION RECEIVED. PATIENT REPORTED AN ISSUE WHEN ATTEMPTING TO INJECT THE STERILE WATER INTO THE VIAL OF WINREVAIR. SHE STATES THERE WAS A LOT OF RESISTANCE WHEN ATTEMPTING TO INJECT THE WATER. SHE TRIED 3 TIMES AND OVER THOSE ATTEMPTS AND BELIEVES ALL THE WATER LEAKED OUT. HOWEVER, SHE IS UNCERTAIN OF WHERE ALL THE LIQUID WENT. CALLER STATES THE POWDER "APPEARS HARD" IN THE VIAL. SHE BELIEVES A SMALL AMOUNT OF STERILE WATER MAY HAVE DRIPPED INTO THE WINREVAIR VIAL. PATIENT STATES SHE DID MISS HER DOSE AND SHE WILL CONTACT CVS SPECIALTY PHARMACY FOR REPLACEMENT AS THIS WAS FILLED THROUGH THE PATIENT ASSISTANCE PROGRAM. SHE IS UNABLE TO EMAIL PICTURES. NO ADDITIONAL DETAILS PROVIDED. NO OTHER AE/PQC REPORTED. DATE PQC OBSERVED: ON (B)(6) 2024.
NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT OF LEAKAGE COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW FOR MATERIAL# 2203E AND LOT# 23105217 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 10OCT2023. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED, AND A ROOT CAUSE COULD NOT BE DETERMINED.
H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
ADDITIONAL INFORMATION RECEIVED. PATIENT REPORTED AN ISSUE WHEN ATTEMPTING TO INJECT THE STERILE WATER INTO THE VIAL OF WINREVAIR. SHE STATES THERE WAS A LOT OF RESISTANCE WHEN ATTEMPTING TO INJECT THE WATER. SHE TRIED 3 TIMES AND OVER THOSE ATTEMPTS AND BELIEVES ALL THE WATER LEAKED OUT. HOWEVER, SHE IS UNCERTAIN OF WHERE ALL THE LIQUID WENT. CALLER STATES THE POWDER "APPEARS HARD" IN THE VIAL. SHE BELIEVES A SMALL AMOUNT OF STERILE WATER MAY HAVE DRIPPED INTO THE WINREVAIR VIAL. PATIENT STATES SHE DID MISS HER DOSE AND SHE WILL CONTACT CVS SPECIALTY PHARMACY FOR REPLACEMENT AS THIS WAS FILLED THROUGH THE PATIENT ASSISTANCE PROGRAM. SHE IS UNABLE TO EMAIL PICTURES. NO ADDITIONAL DETAILS PROVIDED. NO OTHER AE/PQC REPORTED.
MATERIAL # 2203E & BATCH # 23105217. IT WAS REPORTED BY CUSTOMER THAT SYRINGE-VIAL AND ADAPTOR SYSTEM PRESSURE IRREGULARITY, LEAKING FROM ANYWHERE BUT DISPENSING POINT DURING USE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. COVE ID (B)(4). DATE OF COMPANY AWARENESS 20-DEC-24. XXX FG BATCH # Y008782, BD VIAL ADAPTER BATCH 23105217. PQC CATEGORY SYRINGE-VIAL AND ADAPTOR SYSTEM PRESSURE IRREGULARITY, LEAKING FROM ANYWHERE BUT DISPENSING POINT DURING USE. ADDITIONAL INFORMATION REQUIRED. 1. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. DOSAGE NOT RECEIVED BY THE PATIENT. 2. ANY SAMPLE AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? SAMPLE AVAILABLE TO SEND. 3. PLEASE SHARE THE CAPTURED PHOTO OF THE EVENT IF AVAILABLE. 4. COULD YOU PLEASE CONFIRM WHETHER THE DATE OF AWARENESS MENTIONED IN THE EMAIL IS THE DATE OF THE EVENT? IF IT IS NOT, COULD YOU KINDLY PROVIDE THE ACTUAL DATE OF THE EVENT? THE DATE OF AWARENESS IS WHAT IS USED AS THE DATE OF EVENT.
IT WAS REPORTED THAT BD SMARTSITE 13MM VIAL ACCESS DEVICE WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT SYRINGE-VIAL AND ADAPTOR SYSTEM PRESSURE IRREGULARITY - LEAKING FROM ANYWHERE BUT DISPENSING POINT DURING USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 608767 | ALARIS SMARTSITE | INTRAVASCULAR ADMINISTRATION SET | LHI | SISTEMAS MEDICOS ALARIS S.A. DE C.V. | 23105217 | 07613203011792 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |