MAUDE Adverse Event Report: AVANOS MEDICAL INC. BALLARD ACCESS REPLACE CATHETER NEONATE; CATHETERS (DAP)

Model Number	B70811
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	12/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 30 dec 2022 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 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.Device not returned.
Event or Problem Description
Avanos medical inc.Received a single report that referenced four different incidences, which were associated with separate units, involving three different patients.This is the first of four reports.Refer to 8030647-2022-00238 for the second report.Refer to 8030647-2022-00239 for the third report.Refer to 8030647-2022-00240 for the fourth report.The neonatal intensive care unit (nicu) nurse manger reported, the ballad was on the child and their oxygen was at 80% when they noticed the manifold was cracked, (the manifold had been replaced on (b)(6) 2022 and the catheter was changed on (b)(6) 2022); they replaced it.
Additional Manufacturer Narrative
All information reasonably known as of 20 jan 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 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
Correction: g4; h1.The device history record for lot 20098402 was reviewed and the product was produced according to product specifications.The actual sample from the reported event was not returned for evaluation; however, as this is a known issue the sample investigation was reviewed, along with photos provided by the reporter.Visual examination of the photo(s) of the device involved in the reported event confirmed the device was cracked, the reported event could be confirmed as reported.The cause has been traced to manufacturing.All information reasonably known as of 17 aug 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 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 ACCESS REPLACE CATHETER NEONATE
• Common Device Name: CATHETERS (DAP)
• 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: 16081253
• Report Number: 8030647-2022-00237
• Device Sequence Number: 6092625
• Product Code: BSY
• UDI-Device Identifier: 00609038001043
• UDI-Public: 00609038001043
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/23/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: B70811
• Device Lot Number: 20098402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2022
• Supplement Date Received by Manufacturer: 01/05/2023; 08/07/2023
• Initial Report FDA Received Date: 12/31/2022
• Supplement Report FDA Received Date: 01/23/2023; 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2022
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 8 MO
• Patient Sex: Male
• Patient Weight: 5 KG