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

Model Number	60PFS50
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Two (2) samples were received with their original packaging inside a ziploc bag.Samples were inspected at 12 under normal lighting.During the visual inspection, it was seen that both labels had a nonexistent expiration date.Relevant documents, which were reviewed and considered adequate and correct for testing and inspection activities: a review of the manufacturing process, was conducted by quality intern in order to verify that there are no situations or practices that could create the event as described in description of non-conformance? section.All procedures are being carried appropriate.The training was reviewed, and it was confirmed that the personnel had the trainings up to date.During the verification, it was reviewed according to procedure, the first and last label were given the quality touch (all the information of the labels were verified with a check mark comparing to the master sample and the information in the flow chart).The quality touch has been performed by 2 quality inspectors.Once manufacturing receives the labels from qc, 2 manufacturing personnel verifies the labeling is correct by performing the same steps mentioned above.It was seen that: production personnel inspects the first and last label from each lot.During line clearance for packaging, the labels are reviewed by 3 different people to verify the information (2 from production and 1 from quality).When performing the packaging, a 100% inspection to the information on the labels is done by production personnel.Quality inspects the whole information on the first and last printed labels from the lot while printing, this is done by 2 different persons.A final inspection to release the lot, the label is verified by quality inspectors.A representative sample of the lot is reviewed.The root cause is that the expiration date is inserted manually, according to procedure it is added 5 years, but it wasn't seen that it was a leap-year.This issue will be addressed under a capa which was issued on (b)(6)2016.The program used for making the labeling will be changed with this capa.As a preventive action production personnel was notified by area trainer as awareness of the defect reported by the customer.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Date rec¿d by mfr is unknown.No product information has been provided to date.
Event or Problem Description
Customer reports two products labeled with nonexistent expiration dates.No patient injury reported.

• Brand Name: BIVONA TRACHEOSTOMY
• Common Device Name: TUBE, TRACHEOSTOMY
• 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: 15626933
• Report Number: 3012307300-2022-24854
• Device Sequence Number: 12318227
• Product Code: JOH
• UDI-Device Identifier: 15021312005882
• UDI-Public: 15021312005882
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/18/2022

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: 60PFS50
• Device Catalogue Number: 60PFS50
• Device Lot Number: 3167153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 10/18/2022
• 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