BARDEX® I.C. COMPLETE CARE® FOLEY TRAY
Received Aug 15, 2017 · Event occurred Feb 2, 2016
Report 1018233-2017-04231 · MDR key 6796165
Device
Generic name
Componet (syringe)
Manufacturer
Bard Sdn. Bhd. -8040607Catalog number
900016A
Lot number
5HK8018
Product problems
- Crack
- Fluid/Blood Leak
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
UPON FURTHER REVIEW, BARD MEDICAL HAS DETERMINED THAT THIS MDR WAS INITIALLY REPORTED IN ERROR AS THIS EVENT IS NOT REPORTABLE.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A CRACK ON THE SYRINGE. AS A RESULT, WATER LEAKED OUT FROM THE CRACKED AREA DURING PRETEST. COMPLAINT IS BEING ENTERED AS A RESULT OF THE MEDICON RETROSPECTIVE REVIEW.
Additional Manufacturer Narrative
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. THE DEVICE WAS NOT RETURNED.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A CRACK ON THE SYRINGE. AS A RESULT, WATER LEAKED OUT FROM THE CRACKED AREA DURING PRETEST. COMPLAINT IS BEING ENTERED AS A RESULT OF THE MEDICON RETROSPECTIVE REVIEW.