MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. TRACHEOSTOMY PVC - PORTEX TUBES BLUE; TUBE, TRACHEOSTOMY

Catalog Number 100/860/075CZ

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that a missing barcode on the package was observed.Additional information the returned complaint products are unused and there was no patient involvement.

Manufacturer Narrative

Udi is unknown.No information provided to date.This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.One sample was not used and unopened unit pack of 100/860/075cz, b/l ultra suctionaid 7.5mm 10/ca lot 3621962 was received for investigation.Under visual inspection it was noticed that there is missing unit pack label on blister lid.Noted: this issue is mitigated by the fact that inside the blister there is another label (blue patient label) which maintain product traceability.During manufacturing process exact quantity of labels is printed for each work order.The adhesive labels are applied on each blister lid by operator as per work instructions.Actions taken to mitigate the reported issue: missing label is clearly manufacturing issue, therefore whole production staff was retrained.No trend of such complaints nor internal nonconformities (ncrs) was identified.

• Brand Name: TRACHEOSTOMY PVC - PORTEX TUBES BLUE
• Type of Device: TUBE, TRACHEOSTOMY
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; no 678 gubei road; minneapolis, MN 55442
• MDR Report Key: 15599032
• MDR Text Key: 306783795
• Report Number: 3012307300-2022-23881
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K173384
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/860/075CZ
• Device Lot Number: 3621962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1