MAUDE Adverse Event Report: BALLARD CLOSED SUCTION SYSTEM FOR NEONATES / PEDIATRICS, 10 F, Y-ADAPTER; VAP CLOSED SUCTION CATHETERS & ACCESSORIES

Model Number	1910-5
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	06/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record for lot m19135t505 was reviewed and the product was produced according to product specifications.The device were provided by the customer.All information reasonably known as of (b)(6) 2020 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 avanos medical inc.Represents all of the known information at this time.Avanos medical inc.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 avanos medical inc.Complaint database and identified as complaint (b)(4).
Event or Problem Description
It was reported that the "non-return valve" [irrigation port cover] was missing from the device.Patient desaturated to 95% after five minutes.The device was replaced allowing the normalization of the oxygen saturation.Additional information received 29-jun-2020 indicated "the nurse quickly notice[d] the dysfunction, so there was no harmful consequence for the patient.".
Additional Manufacturer Narrative
Photos of the device were provided by the customer.The photos were reviewed; however, no root cause could be determined.All information reasonably known as of 24 oct 2020 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 avanos medical inc.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 avanos medical inc.Avanos medical inc.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 avanos medical inc.Complaint database and identified as complaint (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 avanos medical inc.Product is defective or caused serious injury.

• Brand Name: BALLARD CLOSED SUCTION SYSTEM FOR NEONATES / PEDIATRICS, 10 F, Y-ADAPTER
• Common Device Name: VAP CLOSED SUCTION CATHETERS & ACCESSORIES
• MDR Report Key: 10276027
• Report Number: 8030647-2020-00046
• Device Sequence Number: 14011677
• Product Code: BSY
• UDI-Device Identifier: 00609038983813
• UDI-Public: 00609038983813
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/16/2024
• Device Model Number: 1910-5
• Device Catalogue Number: UNKNOWN
• Device Lot Number: M19135T505
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/25/2020
• Supplement Date Received by Manufacturer: 10/13/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 10/28/2020
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 3 YR