MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ET TUBE, SHER-I-BRONCH, RS, 37 FR; TUBE, TRACHEAL/BRONCHIAL, DIFF

Model Number	IPN049001
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
It was reported "the doctor found product package sealed incompletely during clinical setting before using on patient".No patient involvement reported.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one unit 5-16137 et tube, sher-i-bronch, rs, 37 fr for investigation.The et tube, two suction catheters, both swivel connectors, and the y connector were all returned in their original packaging.The returned sample was visually examined with and without magnification.Visual examination of the returned sample revealed that the ett package was partially opened.No issues were found with the integrity of the sterile barrier on the packaging.A piece of foreign material was observed in the packaging of the et tube, but this could have gotten into the package after it was already opened.The manufacturing site was consulted for this investigation.It was confirmed that the package did not present any blemishes or abnormalities in the sterile barrier.The sterile barrier appears to be fully intact.A burst test is performed at the time of manufacturing to help prevent this type of issue from occurring.Based on the condition of the returned sample, there is no evidence to suggest a manufacturing related root cause.It could not be determined how or when the package was opened.
Event or Problem Description
It was reported "the doctor found product package sealed incompletely during clinical setting before using on patient".No patient involvement reported.

• Brand Name: HUDSON ET TUBE, SHER-I-BRONCH, RS, 37 FR
• Common Device Name: TUBE, TRACHEAL/BRONCHIAL, DIFF
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 12924128
• Report Number: 3003898360-2021-01059
• Device Sequence Number: 17370046
• Product Code: CBI
• UDI-Device Identifier: 14026704617453
• UDI-Public: 14026704617453
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K180253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2021

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 Expiration Date: 09/04/2023
• Device Model Number: IPN049001
• Device Catalogue Number: 5-16137
• Device Lot Number: 73H1800744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2021
• Supplement Date Received by Manufacturer: 12/30/2021
• Initial Report FDA Received Date: 12/03/2021
• Supplement Report FDA Received Date: 01/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown