MAUDE Adverse Event Report: BAYER HEALTHCARE LLC, CONSUMER CARE HYDRASENSE ASPIRATOR FILTERS REFILLS; IRRIGATING SYRINGE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Event Description

This spontaneous case was reported by a consumer and describes the occurrence of accidental device ingestion by a child ('baby swallowed a nasal aspirator filter') in an infant patient who received hydrasense aspirator filters refills nasal spray, solution (batch no.Unk).On an unknown date, the patient started hydrasense aspirator filters refills at an unspecified dose and frequency.The accidental device ingestion by a child (seriousness criterion medically significant) occurred on an unknown date.The reporter commented: their baby swallowed a nasal aspirator filter and wanted to know the composition of the filter.Amendment: the report was amended for the following reason: suspect device coding was updated.No new follow-up information was received from the reporter.Accidental device ingestion by a child is listed according to sodium chloride (hydrasense aspirator filters refills) reference safety information.Moreover, causal relationship cannot be excluded.This case refers to a baby who swallowed a nasal aspirator filter.There was no evidence of device-related defect, malfunction nor any clinical sign, symptom or condition.However there was a potential for harm to the patient in less fortunate circumstances, since the filter has a choking hazard.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a consumer and describes the occurrence of accidental device ingestion by a child ('baby swallowed a nasal aspirator filter') in an infant patient who received hydra nasal aspir starting kit nasal spray, solution (batch no.Unk).On an unknown date, the patient started hydra nasal aspir starting kit.The accidental device ingestion by a child (seriousness criterion medically significant) occurred on an unknown date.The reporter commented: their baby swallowed a nasal aspirator filter and wanted to know the composition of the filter.Quality-safety evaluation of ptc: a ptc investigation cannot be conducted by the quality unit as a batch number or sample was not provided.A quality defect could not be confirmed.The reported event is not indicative of a quality defect per se.Most recent follow-up information incorporated above includes: on 27-mar-2020: quality-safety evaluation of ptc, unconfirmed quality defect, risk category v, update of eu mir and eu/ca device tab.Accidental device ingestion by a child is listed according to hydra nasal aspir starting kit reference safety information.Moreover, causal relationship cannot be excluded.This case refers to a baby who swallowed a nasal aspirator filter.There was no evidence of device-related defect, malfunction nor any clinical sign, symptom or condition.However there was a potential for harm to the patient in less fortunate circumstances, since the filter has a choking hazard.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a consumer and describes the occurrence of accidental device ingestion by a child ('baby swallowed a nasal aspirator filter') in an infant patient who received hydra nasal aspir starting kit nasal spray, solution (batch no.Unk).On an unknown date, the patient started hydra nasal aspir starting kit.The accidental device ingestion by a child (seriousness criterion medically significant) occurred on an unknown date.The reporter commented: their baby swallowed a nasal aspirator filter and wanted to know the composition of the filter.Amendment: the report was amended for the following reason: the suspect product was corrected from hydrasense aspirator filters refills to hydra nasal aspir starting kit.No new follow-up information was received from the reporter.Accidental device ingestion by a child is listed according to hydra nasal aspir starting kit reference safety information.Moreover, causal relationship cannot be excluded.This case refers to a baby who swallowed a nasal aspirator filter.There was no evidence of device-related defect, malfunction nor any clinical sign, symptom or condition.However there was a potential for harm to the patient in less fortunate circumstances, since the filter has a choking hazard.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

• Brand Name: HYDRASENSE ASPIRATOR FILTERS REFILLS
• Type of Device: IRRIGATING SYRINGE
• Manufacturer (Section D): BAYER HEALTHCARE LLC, CONSUMER CARE; 36 columbia road; morristown NJ 07960
• MDR Report Key: 9687194
• MDR Text Key: 189159275
• Report Number: 2248903-2020-00001
• Device Sequence Number: 1
• Product Code: KYZ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Date Manufacturer Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other