MAUDE Adverse Event Report: AVANOS MEDICAL INC. BALLARD MINI-BAL SAMPLING CATHETER 16 F; VAP AIRWAY DIAGNOSTICS BAL-CATH

Model Number	142
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Bradycardia (1751); Foreign Body In Patient (2687)
Date of Event	08/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record is in-progress.The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of 21 sep 2021 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).
Event or Problem Description
It was reported that the patient was undergoing a mini bal [alveolar lavage] procedure on the right lung when the patient's heart rate dropped and ventilator volumes would not return to preprocedural volumes.Et [endotracheal] tube had to be removed from patient's airway.At that time the csc [closed suction catheter] tip was determined to be missing.It was later located and removed.According to the user facility, "followed procedure guidelines, 100% fio2 [oxygen concentration] sxn [suction] prior, turn suction pressure down to 60.Advanced mini bal catheter inside pt [patient] ett [endotracheal tube], till numbers matched.Advancing inner catheter with inspiration.During instillation 30ml of saline was advanced to r [right] side, turned stopcock with no returned sputum, extra pressure noted.Pt started to brady to 51.Volumes on ventilator not returning.Immediately withdrew ett, allowing pt to recover.During this time with catheter withdrawn noted tip of catheter missing.Found missing catheter tip pulled back into catheter." additional information received 02-sep-2021 indicated the mini bal procedure was performed for bronchial sampling.No interventions were needed; the patient had sampling done during bedside tracheotomy.The patient was already intubated at the time of the incident.There were no sequelae from this incident.The csc was in place "briefly, within minutes" when the incident occurred and it had not been altered prior to the reported incident occurring.
Additional Manufacturer Narrative
The device history record for the reported lot number, 30111533, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The returned product was evaluated and no issues were observed on device.The root cause could not be determined since the reported failure was not reproduced in lab during sample evaluation.All information reasonably known as of 27-oct-2021 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
All information reasonably known as of 13-jan-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 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 MINI-BAL SAMPLING CATHETER 16 F
• Common Device Name: VAP AIRWAY DIAGNOSTICS BAL-CATH
• 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: 12509684
• Report Number: 8030647-2021-00039
• Device Sequence Number: 19655550
• Product Code: OYI
• UDI-Device Identifier: 00609038111391
• UDI-Public: 00609038111391
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/14/2022

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: 01/27/2024
• Device Model Number: 142
• Device Catalogue Number: N/A
• Device Lot Number: 30111533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/27/2021
• Supplement Date Received by Manufacturer: 10/01/2021; 12/20/2021
• Initial Report FDA Received Date: 09/21/2021
• Supplement Report FDA Received Date: 10/29/2021; 01/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2021
• 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
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 62 KG