AVANOS, BALLARD ORAL CARE

Additional Manufacturer Narrative

THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 05 MAR 2025 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY SUN MED HOLDINGS LLC. 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 SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE SUN MED HOLDINGS COMPLAINT DATABASE AND IDENTIFIED AS (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

Description of Event or Problem

WHILE THE CRITICAL CARE NURSE WAS PERFORMING ORAL CARE ON THE PATIENT THE SUCTION SWAB FELL APART IN THE PATIENT'S MOUTH AND THE NURSE HAD TO PHYSICALLY REMOVE THE SPONGE AND GREEN TIP FROM THE PATIENT'S MOUTH. THERE WAS NO PATIENT INJURY; THE ORAL CARE DEVICE WAS REPLACED.

Additional Manufacturer Narrative

CORRECTION: G1. ADDITIONAL INFORMATION-INVESTIGATION CONCLUSION: D4; H4; H6. THE PRODUCT INVOLVED IN THE REPORT WAS NOT RETURNED FOR EVALUATION, ADDITIONALLY, NO VISUAL EVIDENCE, SUCH AS PHOTOGRAPHS OR VIDEOS WERE PROVIDED; THEREFORE, A ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD FOR LOT 1562633 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. AS PART OF THE QUALITY CONTROL FOR THE BATCH REPORTED IN THE CUSTOMER COMPLAINT (1562633), 315 UNITS WERE SELECTED AS A REPRESENTATIVE SAMPLE FROM A TOTAL OF (B)(4) UNITS. NO ANOMALIES WERE DETECTED DURING THE QUALITY CONTROL INSPECTION. DURING THE MANUFACTURING OF THE SUBASSEMBLY (SUCTION SWAB) USED FOR PACKAGING PART NUMBER 97021 (BATCH 1562633), A SAMPLE OF 125 UNITS WAS TAKEN FROM A TOTAL OF (B)(4). THE INSPECTION WAS CONDUCTED TO CHECK FOR "MISSING OR UNCONNECTED PARTS" AND "DAMAGE OR BURNS ON THE SPONGE." NO DEFECTS WERE DETECTED. ADDITIONALLY, 20 FORCE TESTS WERE PERFORMED ON THE SPONGE, WITH SATISFACTORY RESULTS. ALL INFORMATION REASONABLY KNOWN AS OF 01 AUG 2025 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY SUN MED HOLDINGS LLC. 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 SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE SUN MED HOLDINGS COMPLAINT DATABASE AND IDENTIFIED AS (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

Description of Event or Problem

WHILE THE CRITICAL CARE NURSE WAS PERFORMING ORAL CARE ON THE PATIENT THE SUCTION SWAB FELL APART IN THE PATIENT'S MOUTH AND THE NURSE HAD TO PHYSICALLY REMOVE THE SPONGE AND GREEN TIP FROM THE PATIENT'S MOUTH. THERE WAS NO PATIENT INJURY; THE ORAL CARE DEVICE WAS REPLACED.