HUDSON ADDIPAK UNIT DOSE SOLUTION
Report
- Report Number
- 1417411-2010-00019
- Event Type
- Other
- Date Received
- June 8, 2010
- Date of Event
- July 8, 2009
- Report Date
- May 14, 2010
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- BTT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
LOT # - THE REPORTED LOT NUMBER OF 0057 IS AN INVALID LOT NUMBER. TYPE OF REPORTABLE EVENT. MISAPPLICATION OF PRODUCT BY END USER. THE DEVICE SAMPLE WAS NOT RETURNED FOR EVAL. EVALUATION CODES, METHOD: COMPLAINT HISTORY REVIEW. RESULTS: HISTORIC INFORMATION REVIEWED FROM 05/20/2008 TO 05/20/2010 SHOWED NO SIMILAR COMPLAINTS FILED FOR THIS PRODUCT CODE AND DEFECT DURING THIS TIME PERIOD. THERE WERE NO SIMILAR COMPLAINTS FILED FOR OTHER PRODUCT CODES IN THE SAME PRODUCT FAMILY/HIERARCHY FOR THIS QUALITY ISSUE. CONCLUSIONS: ROOT CASE: IMPROPER USE AND NOT FOLLOWING THE LABELING GUIDELINES. THE INFORMATION FOR USE FOR THIS PRODUCT CLEARLY STATES THAT IT IS FOR "INHALATION". THE END USER WAS INFORMED/ADVISED, BY TECHNICAL COMPLAINT SPECIALIST, THAT THIS PRODUCT IS NOT INTENDED FOR USE IN THE MANNER THE END USER USED IT.
THE EVENT IS REPORTED BY THE END USER AS: BURNING AND REDNESS IN HER EYES FOR 7-10 DAYS AFTER BEING INSTRUCTED TO PUT ADDIPAK 0.9% SALINE SOLUTION INTO HER EYES PER HER RHEUMATOLOGIST. THE END USER STATES THAT SHE SUFFERS FROM DRY EYES. THE END USER ALSO STATES THAT THE EVENT HAPPENED SOMETIME BETWEEN (B)(6) 2009. MS (B)(6) (END USER) STATED THAT SHE DID NOT SEEK MEDICAL ATTENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUDSON ADDIPAK UNIT DOSE SOLUTION | ADDIPAK UNIT DOSE SALINE SOLUTION | BTT | TELEFLEX MEDICAL | NA | 0057 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |