MAUDE Adverse Event Report: AVANOS MEDICAL INC. BALLARD CLOSED SUCTION SYSTEM FOR NEO/PEDS, 8FR; VAP CLOSED SUCTION CATHETERS & ACCESSORIES

Model Number	198
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Decreased Peak Expiratory Flow rate (2435)
Date of Event	12/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device is reported to be available but has not been returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 01-feb-2023 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.
Event or Problem Description
Avanos medical received a single report that referenced three different incidences, which were associated with separate units, involving three different events.This is the first of three reports.Refer to 8030647-2023-00014 for the second event.Refer to 8030647-2023-00015 for the third event.It was reported "a break in the plastic sheath covering [the] inline ballard suction catheter result[ed] in loss of ventilator pressure to the infant." there was no reported injury.Fda user facility report, (b)(4), received 09-jan-2023 stating, "healthcare provider was preparing for an endotracheal tube (ett) suction of an infant who has frequent large secretions.Healthcare provider had donned gloves and had begun advancing the suction catheter.At some point around 3-5 cm of advancement, healthcare provider noticed that the suction catheter was exposed due to a large split in the plastic sheath covering.Healthcare provider immediately withdrew the catheter and restrained the infant from self-extubating (high risk airway) while calling the respiratory therapist (rt) to provide a replacement ballard suction catheter.The new catheter sheath was noted to have a different feel than the usual one - more thick and less flexible to touch.The old catheter was saved and given to rt.It was an 8 fr ballard, lot: 30215783." additional information received 17-jan-2023 stated the catheter was in use for and unknown period of time prior to the failure.
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of 24-feb-2023 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.
Additional Manufacturer Narrative
The device history record for the reported lot number, 30215783, was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.The sample was received without the original pouches packaging.No other components received.The device was evaluated.The returned closed suction catheter was examined after decontamination and air drying of devices.The closed suction catheter was photographed to show the appearance of tearing effect horizontally.The tearing on sleeve was located somewhere near the part line/ seam of the sleeve started from the manifold area until near the cone adapter which could have made the catheter exposed.Root cause could not be determined.All information reasonably known as of 05-apr-2023 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 NEO/PEDS, 8FR
• Common Device Name: VAP CLOSED SUCTION CATHETERS & ACCESSORIES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT S DE RL DE CV; carretera internacional; salida norte no. 1053; magdalena, cp
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 16281469
• Report Number: 8030647-2023-00013
• Device Sequence Number: 14707365
• Product Code: BSY
• UDI-Device Identifier: 00609038938264
• UDI-Public: 00609038938264
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 198
• Device Catalogue Number: N/A
• Device Lot Number: 30215783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2023
• Supplement Date Received by Manufacturer: 02/03/2023; 03/10/2023
• Initial Report FDA Received Date: 02/01/2023
• Supplement Report FDA Received Date: 02/27/2023; 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 2 WK
• Patient Sex: Male
• Patient Weight: 4 KG