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

Model Number	67SP055
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was noted samples received: ten (10) samples were received; four (4) in new conditions inside their closed original packaging from p/n 67sp040 l/n 33926962, one (1) in used conditions from p/n 67sp045 l/n 3917995 without its original packaging and five (5) in used conditions from 67sp055 3926963 without its original packaging.Visual inspection: visual inspection was performed at 12? under normal lighting to received units, in order to detect any damage on the cuff, airline or pilot balloon.No damaged could be detected.Functional test: samples were filled with 5cc of air according to mp bivona tt-tj130 rev.102 ? (wi-mfg/inspect instructions) in order to see if there was any functional problem.Results: when we inflated the sample 1, 2, 3,4,5,7, 9 and 10 with air, the cuff only inflated one side.According to the ifu (10018853-001 rev.100 - ifu - pedi/neo tts (pnt)) we manipulated the pilot balloon and the cuff inflated but only one side, we manipulated the cuff and the whole cuff inflated.After the whole cuff inflated, we deflated and inflated 4 times, all the times the cuff inflated completely.However, cuff from sample 1,3 and 5 sees asymmetrical.When we inflated the sample 7, the pilot ballon inflated but all the air was stuck it.According to the ifu (10018853-001 rev.100 - ifu - pedi/neo tts (pnt)) we manipulated the pilot balloon and the cuff inflated but only one side, we manipulated the cuff and the whole cuff inflated.After the whole cuff inflated, we deflated and inflated 4 times, all the times the cuff inflated completely.By last, sample 8 inflated without problems.Functional test: air cuff symmetry test was performed to the units according to mp bivona tt-tj130 rev.102 ? wi-mfg/inspect instructions and av-10006853 rev.101 - leak testing and cuff symmetry visual aid.Cuff symmetry fixtures were used (id: 13.2684-40 due: 02/21) , (id: 13.2684-45 due: 02/21) and (id: 13.2684-55 due: 02/21).When we measured the cuffs, the percentage for the symmetry was for sample (b)(4).The results from sample 1 and 3 are below (b)(4) that is the minimum acceptable.Based on the test, the units 1 and 3 are out spec.The complaint is confirmed.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that the cuff not evenly inflating.Cuff sticking to the plastic molded container.No patient injury reported.

• Brand Name: BIVONA
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15446447
• Report Number: 3012307300-2022-19631
• Device Sequence Number: 4750929
• Product Code: JOH
• UDI-Device Identifier: 15021312000757
• UDI-Public: 15021312000757
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/19/2022

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: Health Professional
• Device Model Number: 67SP055
• Device Catalogue Number: 67SP055
• Device Lot Number: 3926963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2022
• Initial Report FDA Received Date: 09/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown