MAUDE Adverse Event Report: AVANOS MEDICAL INC. BALLARD CS NEO/PED, 6 FR, ELBOW MANIFOLD; VAP CLOSED SUCTION CATHETERS & ACCESSORIES

Model Number 200

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2021

Event Type  malfunction  

Manufacturer Narrative

The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is in-progress.All information reasonably known as of 29-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.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 Description

It was reported, "the tip end of the suction catheter broke off and was noticed in the part of the adaptor that attaches to the endotracheal tube.The clinician was unaware it came off, but seen the black band and disconnected the ballard to retrieve the object and then realized it was the tip of the suction tube." the broken part was not in the patient's endotracheal tube nor the patient's lung(s).Additional information received on 14-oct-2021 stated the device was not altered.The patient was doing well.The patient remains on the jet ventilator at 21% fio2 at the time of this information.Infant did not require re-intubation since the piece was in part of the endotracheal tube adaptor.

Manufacturer Narrative

The device history record for the reported lot number, 30109604, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The returned closed suction catheter was not received with the original packaging.It was received with 3 different sizes ports and a day sticker with an unknown clear component (not avanos product).The device was evaluated.The catheter was fully advanced to inspect the entirety of the tip area.Approximately 4.5cm from the 5cm marking of the catheter, jagged edges on the catheter tip was seen.The black marking near the tip of the catheter was not present as well as the 2 skives after reviewing the area under magnification.The root cause was related to a manufacturing deficiency.All information reasonably known as of (b)(6) 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.

• Brand Name: BALLARD CS NEO/PED, 6 FR, ELBOW MANIFOLD
• Type of Device: 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: 12725064
• MDR Text Key: 282342943
• Report Number: 8030647-2021-00043
• Device Sequence Number: 1
• Product Code: BSY
• UDI-Device Identifier: 00609038938271
• UDI-Public: 00609038938271
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 200
• Device Catalogue Number: N/A
• Device Lot Number: 30109604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 37 DA
• Patient Sex: Male