MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC BIVONA CUSTOM TUBES; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	CMZ3289N
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/28/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tracheostomy tube was disconnected from the iso connector, the iso connector detached from the rest of the cannula leaving no connection to the ventilator.An unplanned replacement cannula had to be inserted promptly.In addition, a resuscitator was also used on the patient.No additional adverse patient effects.
Additional Manufacturer Narrative
Device evaluation: visual inspection of the returned device confirmed that the retaining ring, which keeps the swivel connector in place was missing.Inside the grove, which holds the retaining ring, there was foreign matter identified as paper.Further inspection of the groove, revealed the presence of adhesive, which is used to secure the retaining ring to the neck flange.Review of the dhr showed that operation (adhesive retaining ring) was performed by the operator and that the quality inspector verified that there was adhesive applied to the retaining ring.The attachment provide by the complainant was shared with the molding engineer, who inspected the mold that is used to produce the neck flange.No mold damage was observed.Sample parts from each of the four cavities of the mold were removed from inventory.All parts were inspected and found to have the proper geometry for where the retaining ring is placed.The returned part did exhibit a sloping surface for the retaining ring.The device was cut and examined under magnification.The sloping surface was a result of the adhesive that is applied to secure the retaining ring in place.The process is for the assembler to place the retaining ring inside the molded grove on the neck flange and insert a needle along the side of the retaining ring to apply adhesive.After the needle applying adhesive traces the entire circumference of the ring, the excessive adhesive that oozes out of the groove is smoothed on top of the surface.It is likely that the ring lifted at the one area that is higher when adhesive was applied and the ring was not reseated during the finishing process.This allowed the extra adhesive to buildup under the ring.Since the amount of adhesive is manually controlled by the operator and is not metered during dispensing, a quality alert, qa19-004, was initiated to heighten awareness to the concern and to provide a visual aide to the operator for a correctly seated retaining ring.The custoemr reported condition was confirmed.

• Brand Name: BIVONA CUSTOM TUBES
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8634220
• Report Number: 3012307300-2019-03676
• Device Sequence Number: 1655761
• Product Code: JOH
• UDI-Device Identifier: 15019517148688
• UDI-Public: 15019517148688
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2019

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: No Information
• Device Expiration Date: 04/30/2023
• Device Model Number: CMZ3289N
• Device Catalogue Number: CMZ3289N
• Device Lot Number: DS015988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/01/2001
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2019
• Supplement Date Received by Manufacturer: 05/23/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 06/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1