BD MAXZERO MULTI-FUSE PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR(S)
Report
- Report Number
- 9616066-2025-00251
- Event Type
- Malfunction
- Date Received
- February 14, 2025
- Date of Event
- January 28, 2025
- Report Date
- April 11, 2025
- Manufacturer
- SISTEMAS MEDICOS ALARIS S.A. DE C.V.
- Product Code
- FPA
- PMA / PMN Number
- K140831
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
B.3. THE DATE OF EVENT IS UNKNOWN; AWARENESS DATE USED. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
NO MZ5305 SAMPLE WAS AVAILABLE FOR INVESTIGATION. THE CUSTOMER REPORTED THAT THE AFFECTED SAMPLE WAS FROM LOT: 24099033 AND THAT "AT THE TIME OF CATHETER INSERTION, AFTER PULSED RINSING AND PURGING OF THE EXTENDER, REFLUX WAS OBSERVED OUTSIDE THE VALVE, CAUSING BLOOD TO FLOW INTO THE PATIENT'S BED." AS PART OF THE INVESTIGATION, THE CUSTOMER PROVIDED A PHOTOGRAPH OF THE AFFECTED SAMPLE; ANALYSIS OF THE PHOTOGRAPH WAS UNABLE TO IDENTIFY THE ROOT CAUSE OF THE CUSTOMER'S EXPERIENCE AS NO LEAKAGE WAS VISIBLE FROM THE MZ5305. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE COULD NOT BE DETERMINED AS THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. IN THIS INSTANCE, WITHOUT A SAMPLE, IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER¿S EXPERIENCE. A REVIEW OF THE PRODUCTION RECORDS FOR LOT: 24099033 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. ALTHOUGH IT WAS NOT POSSIBLE TO DETERMINE A DEFINITIVE ROOT CAUSE FOR THIS ISSUE, THE QUALITY TEAM AT THE MANUFACTURING SITE HAS BEEN INFORMED OF THIS COMPLAINT IN ORDER TO BE AWARE OF THE REPORTED FAILURE MODE DURING FUTURE PRODUCTION OF THIS PRODUCT. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT COMPLAINTS OF THIS NATURE ARE RARE AND THERE IS CURRENTLY NO TREND FOR ISSUES OF THIS NATURE AGAINST THE MZ5305 PRODUCT.
INVESTIGATION RESULT: ONE MZ5305 SAMPLE WAS RECEIVED WITHOUT PACKAGING FOR INVESTIGATION; NO CONNECTING PRODUCT WAS PROVIDED TO AID THE INVESTIGATION, FURTHERMORE RESIDUAL BLOOD WAS PRESENT WITHIN THE SET. THE CUSTOMER REPORTED THAT THE AFFECTED SAMPLE WAS FROM LOT 24099033 AND THAT "AT THE TIME OF CATHETER INSERTION, AFTER PULSED RINSING AND PURGING OF THE EXTENDER, REFLUX WAS OBSERVED OUTSIDE THE VALVE, CAUSING BLOOD TO FLOW INTO THE PATIENT'S BED." AS PART OF THE INVESTIGATION, THE CUSTOMER PROVIDED A PHOTOGRAPH OF THE AFFECTED SAMPLE; ANALYSIS OF THE PHOTOGRAPH WAS UNABLE TO IDENTIFY THE ROOT CAUSE FOR THE CUSTOMER'S EXPERIENCE. THE RETURNED SAMPLE WAS SUBJECTED TO PRESSURE TESTING IN ORDER TO REPLICATE THE CUSTOMER'S EXPERIENCE; HOWEVER NO LEAKAGE WAS OBSERVED FROM THE INFUSION SET THROUGHOUT TESTING. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. IN THIS INSTANCE, A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED AS TESTING OF THE RETURNED SAMPLE DID NOT IDENTIFY ANY PRODUCT DEFECTS OR QUALITY DEVIATION THAT COULD HAVE CONTRIBUTED TO THE CUSTOMER¿S EXPERIENCE. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 24099033 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. PLEASE NOTE THE MAXZERO IS NOT A BACK CHECK VALVE AND UNDER CERTAIN CIRCUMSTANCES IT IS POSSIBLE FOR BLOOD TO BACK FLOW INTO THE MAXZERO; SUCH A PHENOMENON CAN OCCUR IF THE PATIENT HAS HIGH BLOOD PRESSURE. AS STATED IN THE DIRECTIONS FOR USE "FLUSH THE MAXZERO AFTER EACH USE WITH NORMAL SALINE OR IN ACCORDANCE WITH FACILITY PROTOCOL." AND "FAILURE TO PROPERLY PRIME THE DEVICE CAN RESULT IN REFLUX". ALTHOUGH IT WAS NOT POSSIBLE TO DETERMINE A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER'S EXPERIENCE, THE QUALITY TEAM AT THE MANUFACTURING SITE HAS BEEN INFORMED OF THIS COMPLAINT IN ORDER TO BE AWARE OF THE REPORTED FAILURE MODE DURING FUTURE PRODUCTION OF THIS PRODUCT. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT THIS IS A RARE OCCURRENCE WITH THIS CUSTOMER BEING THE ONLY CUSTOMER TO PROVIDE THIS TYPE OF FEEDBACK AGAINST THE MZ5305 PRODUCT IN THE PAST 12 MONTHS.
¿IT WAS REPORTED THAT THE BD MAXZERO MULTI-FUSE PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR(S) WAS LEAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: WE HAVE HAD 3 REPORTS RELATING TO BIDIRECTIONAL VALVES WITH MAXZERO EXTENDER (REF: MZ5305, BATCH: 24099033) IN PEDIATRIC HDJ. WHEN PLACING THE CATHETER AND AFTER PERFORMING THE PULSED FLUSH AND PURGING THE EXTENDER, REFLUX WAS OBSERVED OUTSIDE THE VALVE CAUSING A FLOW OF BLOOD INTO THE PATIENT'S BED. WE HAVE NOT HAD ANY PROBLEMS IN OTHER SERVICES AND THE ASSEMBLY DIAGRAM SEEMS TO BE CORRECT. I CAN'T YET TELL IF IT'S A MISUSE OR A PROBLEM WITH THE DEVICE.
WE HAVE RECEIVED 3 REPORTS CONCERNING MAXZERO BIDIRECTIONAL VALVES WITH EXTENSION (REF: MZ5305, BATCH: 24099033) IN PEDIATRIC HDJ. AT THE TIME OF CATHETER INSERTION, AFTER PULSED RINSING AND PURGING OF THE EXTENDER, REFLUX WAS OBSERVED OUTSIDE THE VALVE, CAUSING BLOOD TO FLOW INTO THE PATIENT'S BED. WE HAVEN'T HAD ANY PROBLEMS IN OTHER DEPARTMENTS, AND THE ASSEMBLY DIAGRAM SEEMS TO BE CORRECT. I'M STILL NOT SURE WHETHER THIS IS A MISUSE OR A PROBLEM WITH THE DEVICE. TRAINING COURSES WILL BE ORGANIZED AT OUR FACILITY TO REVIEW PRACTICES.
NO ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1460555 | BD MAXZERO MULTI-FUSE PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR(S) | INTRAVASCULAR ADMINISTRATION SET | FPA | SISTEMAS MEDICOS ALARIS S.A. DE C.V. | 24099033 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |