BARD NAVARRE UNIVERSAL GRAVITY DRAINAGE BAG

Additional Manufacturer Narrative

AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A MANUFACTURING REVIEW WILL BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. 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.

Description of Event or Problem

IT WAS REPORTED THAT THE BLUE CONNECTION AT THE BOTTOM OF THE BAG WOULD NOT STAY CLOSED. THERE WAS NO REPORTED PATIENT INJURY.

Additional Manufacturer Narrative

MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, SUBASSEMBLIES, MANUFACTURING PROCESS, AND QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS LOT NUMBER AND FAILURE MODE. INVESTIGATION SUMMARY: THE DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE ALLEGED REPORTED FAILURE. THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. IT IS UNKNOWN WHETHER PATIENT AND/OR PROCEDURAL FACTORS CONTRIBUTED TO THE EVENT. LABELING REVIEW: A REVIEW OF PRODUCT LABELING DOCUMENTS (E.G., PROCEDURAL INSTRUCTIONS, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, CONTRAINDICATIONS, NURSING GUIDE, AND UNIT LABEL) SHOWED THAT THE PRODUCT LABELING IS ADEQUATE.

Description of Event or Problem

IT WAS REPORTED THAT THE BLUE CONNECTION AT THE BOTTOM OF THE BAG WOULD NOT STAY CLOSED. THERE WAS NO REPORTED PATIENT INJURY.