NOT APPLICABLE
Report
- Report Number
- 1321116-2023-00001
- Event Type
- Malfunction
- Date Received
- September 8, 2023
- Date of Event
- July 1, 2023
- Report Date
- September 29, 2023
- Manufacturer
- FRESENIUS KABI USA, LLC
- Product Code
- NZW
- PMA / PMN Number
- K092938
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
FOLLOW-UP #1: FINAL INVESTIGATION REPORT - INVESTIGATION FINDINGS: NO MANUFACTURING ISSUES WERE IDENTIFIED THAT WOULD HAVE LED TO THE CURRENT COMPLAINT. FORMULATION DOCUMENTATION WAS REVIEWED, AND ALL REQUIREMENTS WERE MET FOR MASS AND VOLUME MEASUREMENTS, MIXING TIMES, TEMPERATURES, AND PH ADJUSTMENTS. NO ANOMALIES WERE IDENTIFIED IN THE FORMULATION OR FILLING PROCESS DOCUMENTATION THAT WOULD CAUSE OR CONTRIBUTE TO THE SUBJECT COMPLAINT. REPRESENTATIVE RESERVE SAMPLES WERE TESTED FOR ASSAY AND THE RESULTS WERE WITHIN SPECIFICATION OF 99.9% (LIMIT 90.0 - 120.0%). NO TREND IS ASSOCIATED WITH THIS COMPLAINT.
QUALITY ASSURANCE INITIAL IMPACT ASSESSMENT: BATCH 6028094 IS NOT IN THE STABILITY PROGRAM, HOWEVER, THE BATCH ON STABILITY FOR PRODUCT CODE 504901 CONTINUES TO MEET SPECIFICATIONS AT EACH TEST STATION INCLUDING ASSAY TESTING. FINAL INVESTIGATION REPORT STATUS: IN PROGRESS AND WILL BE PROVIDED IN A FOLLOW-UP TO THIS MDR.
FOLLOW-UP #1: FINAL INVESTIGATION REPORT - INVESTIGATION FINDINGS: NO MANUFACTURING ISSUES WERE IDENTIFIED THAT WOULD HAVE LED TO THE CURRENT COMPLAINT. FORMULATION DOCUMENTATION WAS REVIEWED, AND ALL REQUIREMENTS WERE MET FOR MASS AND VOLUME MEASUREMENTS, MIXING TIMES, TEMPERATURES, AND PH ADJUSTMENTS. NO ANOMALIES WERE IDENTIFIED IN THE FORMULATION OR FILLING PROCESS DOCUMENTATION THAT WOULD CAUSE OR CONTRIBUTE TO THE SUBJECT COMPLAINT. REPRESENTATIVE RESERVE SAMPLES WERE TESTED FOR ASSAY AND THE RESULTS WERE WITHIN SPECIFICATION OF 99.9% (LIMIT 90.0 - 120.0%). NO TREND IS ASSOCIATED WITH THIS COMPLAINT.
MAY HAVE BEEN A LACK OF EFFECT (LACK OF DRUG EFFECT, DRUG INEFFECTIVE). PICC [PERIPHERALLY INSERTED CENTRAL CATHETER] LINES CLOTTED (VASCULAR DEVICE OCCLUSION, VASCULAR DEVICE OCCLUSION). TWO NEONATAL PATIENTS WERE ADMINISTERED THE PRODUCT (OFF LABEL USE IN UNAPPROVED AGE GROUP, OFF LABEL USE). COUNTRY OF OCCURRENCE: UNITED STATES OF AMERICA. INTERNAL CASE REFERENCE NUMBER (B)(4) IS A SPONTANEOUS CASE RECEIVED ON 08-AUG-2023 FROM A HEALTH PROFESSIONAL THAT REFERS TO A NEONATAL PATIENT (PATIENT 1), IN WHICH AGE, GENDER, AND WEIGHT WERE NOT REPORTED. PATIENT'S MEDICAL HISTORY WAS NOT REPORTED. CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNKNOWN DATE IN 2023 (OVER THE LAST SEVERAL WEEKS), THE PATIENT RECEIVED HEPARIN LOCK FLUSH SOLUTION (NDC 63323-549-01, LOT 6028094 WITH EXPIRY JUL-2024, CONCENTRATION: (B)(4) UNITS/ML, STRENGTH: (B)(4) UNITS, ROUTE: IV VIA PICC LINE) TO PREVENT CLOTTING. ON AN UNKNOWN DATE IN 2023 (OVER THE LAST SEVERAL WEEKS), THE PATIENT WAS ADMINISTERED THE PRODUCT (OFF LABEL USE) AND THERE MAY HAVE BEEN A LACK OF EFFECT AS THEIR PICC LINE CLOTTED. ACTION TAKEN WITH THE SUSPECT DRUG HEPARIN LOCK FLUSH SOLUTION WAS UNKNOWN. RELEVANT TESTS/LABORATORY DATA WERE NOT PROVIDED. ON AN UNKNOWN DATE, OUTCOME WAS UNKNOWN FOR EVENTS OF OFF LABEL USE AND THERE MAY HAVE BEEN A LACK OF EFFECT AS THEIR PICC LINE CLOTTED. THE CASE WAS CONSIDERED SERIOUS. PHARMACOVIGILANCE ASSESSMENT: AS PER USPI, THE EVENTS VASCULAR DEVICE OCCLUSION AND OFF LABEL USE ARE UNLISTED AND THE EVENT DRUG INEFFECTIVE IS LISTED FOR THE SUSPECT HEPARIN. LACK OF INFORMATION REGARDING THE DRUG EVENT END LATENCY PRECLUDES A MEANINGFUL ASSESSMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 615348 | NOT APPLICABLE | HEPARIN LOCK FLUSH SOLUTION, USP | NZW | FRESENIUS KABI USA, LLC | 6028094 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention| O | CONCOMITANT MEDICATIONS WERE NOT REPORTED |