MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX GENERAL ANESTHESIA CIRCUITS; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	ZZ19KN70ZZZ006N
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a pre-use check, the customer found a torn hole in the product.No patient injury reported.
Additional Manufacturer Narrative
Visual inspection: the sample was visually inspected at a distance of 12" under normal lighting to received units, in order to detect any damage on the unit.The breathing bag have a tear.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 b10009406, as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX GENERAL ANESTHESIA CIRCUITS
• 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; 3-10-15, hakata station east,; minneapolis, MN 55442
• MDR Report Key: 15461057
• Report Number: 3012307300-2022-19908
• Device Sequence Number: 3050284
• Product Code: JOH
• UDI-Device Identifier: 15019517209983
• UDI-Public: 15019517209983
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2022

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: ZZ19KN70ZZZ006N
• Device Catalogue Number: ZZ19KN70ZZZ006N
• Device Lot Number: 3862080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2022
• 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: 09/21/2022
• 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