MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. BLUSELECT, NON-FENESTRATED, BLUSELECT, NON-FENESTR; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	101/810/070CZ
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.One not opened unit pack was received in plastic bag for investigation.Under visual inspection we noticed that there is 1cm diameter hole in the blister as described by customer.Hole in the blister is a nonconformity which is described in a nonconformity record(ncr).Within this ncr whole on hand stock of blisters was 100% sorted prior to the packaging process.The reported issue was confirmed.The most probable root cause is that blister with the hole which is subject of this complaint was not rejected during this sorting.No more escapes from this sorting were reported via customer complaints.This issue was escalated to the supplier.As corrective action supplier implemented 100% in-line leak tester.Affected blister was manufactured prior to implementation of this corrective action.Operator of device is unknown.Initial reporter also sent report to fda is unknown.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 a hole was seen on the packaging of the product.The product is not sterile.No patient injury was reported.

• Brand Name: BLUSELECT, NON-FENESTRATED, BLUSELECT, NON-FENESTR
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15456526
• Report Number: 3012307300-2022-19612
• Device Sequence Number: 17852988
• Product Code: BTO
• UDI-Device Identifier: 15019517076288
• UDI-Public: 15019517076288
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K173384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/20/2022

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
• Device Model Number: 101/810/070CZ
• Device Catalogue Number: 101/810/070CZ
• Device Lot Number: 3887478
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown