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

Catalog Number	FT18HN35NGE895N
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One custom 3.5 flextend tts was received at msou for investigation.Based on the part number contained in the customer correspondence, it was confirmed that the part was built in (b)(4).Immediately upon receipt of the part, it was clear that there was some sort of hole/"gash" in the cuff.The returned part was found to exhibit a similar issue to this customer's previous complaint (refer to (b)(4)).Upon looking closer at the "gash" it appeared that a chunk of material from the cuff was actually missing (as opposed to a slice or puncture which created a hole).It cannot be determined how or when this gash occurred; however, all parts are subject to a leak test and visual inspection after the manufacturing process.This inspection would be expected to detect the type of issue observed in this complaint sample and for this reason it is presumed to have occurred sometime after the product was shipped.It is possible that the device had come in contact with a sharp object or was over-inflated.In summary, an inflation issue was confirmed, but it was unable to be determined what led to this issue.Msou has not received any other complaints (besides these 2 from the same customer) where there appeared to be a large gash of a tts cuff missing from the device.For this reason, and the assumption that this issue was not present upon leaving the manufacturing facility, no corrective action is determined to be necessary at this time.A notification will be sent to the clinical education team to assess whether any further discussion/training should be pursued.Smiths medical regularly monitors complaints for trends and takes investigation/additional corrective action as necessary.
Event or Problem Description
It was reported that after two weeks of use, the cuff gave out.This was noticed while the trach was being reprocessed.No death or serious injury was reported in connection with this incident.
Additional Manufacturer Narrative
One tracheostomy was returned for evaluation.Upon visual inspection of the device, a hole was noted in the cuff.It appeared to have a chunk of material missing as opposed to a cut in the cuff.All parts are subject to a leak test and visual inspection after the manufacturing process.A possible root cause is attributed to the device coming in contact with a sharp object or was over-inflated.However, the customer states that this issue was noted during reprocessing, which might mean that the damage was caused during reprocessing/cleaning the product.The customer's complaint was confirmed, however no definitive root cause to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.

• Brand Name: SILICONE - BIVONA TUBES CUSTOM
• 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: 7958418
• Report Number: 3012307300-2018-04216
• Device Sequence Number: 16728883
• Product Code: JOH
• UDI-Device Identifier: 15019517163018
• UDI-Public: 15019517163018
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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): 11/02/2018

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: No Information
• Device Expiration Date: 08/27/2023
• Device Catalogue Number: FT18HN35NGE895N
• Device Lot Number: SS016858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2018
• Supplement Date Received by Manufacturer: 10/05/2018
• Initial Report FDA Received Date: 10/11/2018
• Supplement Report FDA Received Date: 11/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1