MAUDE Adverse Event Report: GYRUS ACMI, INC COLLAR BUTTON VENT TUBE (30/PK); TUBE, TYMPANOSTOMY

Model Number	70241314
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer returned a box of 25 unopened and sealed packages of the 70241314 vent tubes (lot lz845980) for evaluation due to ¿patient infections¿.The manufacturer performed a visual inspection on four out of the twenty-five vent tubes, and was unable to replicate the user¿s complaint.First verified was the condition of the sealed, sterile package(s), which had no perforations, cuts, or irregularities.The sealing on the edge of the packages were well sealed and intact prior to opening.The condition of the blue plastic dispenser casing that encloses the actual vent tube was checked and verified that the case opens and closes properly.Additionally, the silicone vent tube inside the case shows no signs of defects or other issues.The use by date printed on the packages are well within their time.The inner diameter and flare of the device was measured according to the information provided in the manual; the inner diameter is approximately 1.27mm and the inner flare is 1.5mm which was measure using the caliper.A device history review (dhr) review was performed and no abnormalities in documentation or process was found.The important medical information sheet provided in the device packaging, states the following, ¿this product is for single use only.It has not been designed to be re-used or re-sterilized.Reprocessing may lead to changes in material characteristics such as metallic corrosion and dulled edges, ceramic and plastic deformation, or splitting which may impact the strength of the device and compromise device performance.Reprocessing of single use devices can also cause cross contamination leading to patient infection.These risks may potentially affect patient safety.Based on the evaluation, the manufacturer was unable to find any product abnormalities during the inspection.The manufacturer will continue to investigate the reported event.If any additional information becomes available that changes the facts or conclusions of this report supplemental report will be submitted accordingly.
Event or Problem Description
The company representative reported a total of 15 cases of patient infections since (b)(6) 2019 for the same facility.Two cases of infections on this 70241314 vent tube with lot # lz845980.Two cases of infections on this 70241314 vent tube with lot # nc740479 two cases of infections on this 70241314 vent tube with lot # mh693598 two cases of infections on this 70241314 vent tube with lot # s835440 seven cases of infections on this 70241314 vent tube with lot # nc785867 complaint 1 of 15.
Additional Manufacturer Narrative
This supplemental report is being submitted to report the device evaluation results.The customer returned a box of 25 unopened and sealed packages of the 70241314 vent tubes (lot lz845980) for evaluation due to ¿patient infections¿.A visual inspection was performed on four of the twenty-five vent tubes that were returned, and verified the condition of the sealed, sterile package(s), which had no perforations, cuts, or irregularities.The sealing on the edge of the packages were well sealed and intact prior to opening.The condition of the blue plastic dispenser casing that encloses the actual vent tube was inspected and verified that the case opens and closes properly.Additionally, the silicone vent tube inside the case shows no signs of defects or other issues.The use by date printed on the packages are well within their time.The inner diameter and flare of the device was measured according to the information provided in the manual; the inner diameter is approximately 1.27mm and the inner flare is 1.5mm which was measure using the caliper.The cause of the reported event cannot be determined.The important medical information sheet provided in the device packaging, states the following, ¿this product is for single use only.It has not been designed to be re-used or re-sterilized.Reprocessing may lead to changes in material characteristics such as metallic corrosion and dulled edges, ceramic and plastic deformation, or splitting which may impact the strength of the device and compromise device performance.Reprocessing of single use devices can also cause cross contamination leading to patient infection.These risks may potentially affect patient safety.¿.
Additional Manufacturer Narrative
Correction for supplemental 1.The customer returned another box of 30 unopened and sealed packages of the 70241314 vent tubes (lot lz845980) for evaluation due to ¿patient infections¿.The manufacturer performed a visual inspection on four out of the thirty vent tubes, and was unable to replicate the user¿s complaint.First verified was the condition of the sealed, sterile package(s), which had no perforations, cuts, or irregularities.The sealing on the edge of the packages were well sealed and intact prior to opening.The manufacturer proceeded to check the condition of the blue plastic dispenser casing that encloses the actual vent tube, and verified that the case opens and closes properly.Additionally, the silicone vent tube inside the case shows no signs of defects or other issues.The use by date printed on the packages are well within their time.The inner diameter and flare of the device was measured according to the information provided in the manual; the inner diameter is approximately 1.27mm and the inner flare is 1.5mm which was measured using the caliper.The important medical information sheet provided in the device packaging, states the following, ¿this product is for single use only.It has not been designed to be re-used or re-sterilized.Reprocessing may lead to changes in material characteristics such as metallic corrosion and dulled edges, ceramic and plastic deformation, or splitting which may impact the strength of the device and compromise device performance.Reprocessing of single use devices can also cause cross contamination leading to patient infection.These risks may potentially affect patient safety.¿ additionally, the customer also returned a box of sealed vent tubes (30 total sealed devices) with the lot number me825206 for evaluation.The devices were checked in the same manner as the ones inspected from lot lz845980; no deviations noted.Four out of the thirty devices were evaluated.Based on the evaluation, the manufacturer was unable to duplicate the user¿s request during the inspection.The packaging for the sealed devices were checked for voids and/or damages; however, none were found.
Additional Manufacturer Narrative
This supplemental report is being submitted to report the device evaluation results and provide the device manufacture date.Please the updates in sections: d10, g4, g7, h2, h3, h4, h6 and h10.The customer returned 20 boxes of model 70241314.This lot was composed of two lots of blank 1186172 lot #s lz8483318 and lz843315 both of completed 600 units.These blank lots were made from silicone material 0450002 lot# me823403 which was blended on dec 5th 2018 from compound 0385012 lot #84142, blue silicone 2430090 lot # 814390 and white silicone 2430092 lot # 670703.There are no indication from receipt or dhr records that there was any abnormality with any of the materials used to create the finished good 70241314.This performance report did not find any evidence that there was any manufacturer related issue that contributed to this reported instance.Outside of going through the normal blending, molding and packaging process, the only common component between all of the reported impacted lots (nc740479, lz845980, sm835440, nc785867, mh693598) is the white silicone material 2430092 lot# 670703 was used to blend into all of the material.This material has been in use since june of 2014 with no other reported instances before this reported instance.
Additional Manufacturer Narrative
This supplemental report is being submitted to correct the event date.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information received and correct the event date.Additional information received from the user facility states that the patient underwent a firv lmt procedure.The facility reported that the patient had no ear pain after the tubes were removed.A review of the patient¿s medical was performed and found the following: (b)(6) 2019: post op call.Severe ear pain on the left side.(b)(6) 2019: follow up.Pain still there; possible otic shingles; valtrex prescribed.(b)(6) 2019: surgery.Left ear tube removal.(b)(6) 2019: telephone call.Sinus infection; no complaints of ear pain.

• Brand Name: COLLAR BUTTON VENT TUBE (30/PK)
• Common Device Name: TUBE, TYMPANOSTOMY
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 8948290
• Report Number: 2951238-2019-01076
• Device Sequence Number: 19450802
• Product Code: ETD
• UDI-Device Identifier: 00821925032040
• UDI-Public: 00821925032040
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K960477
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/05/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 70241314
• Device Lot Number: LZ845980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/02/2019
• Supplement Date Received by Manufacturer: 09/04/2019; 12/04/2019; 01/15/2020; 09/13/2019; 06/04/2020
• Initial Report FDA Received Date: 08/29/2019
• Supplement Report FDA Received Date: 10/02/2019; 12/04/2019; 02/04/2020; 06/04/2020; 06/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1