MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PRO-VENT SHARPS SAFETY; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS,

Catalog Number G1463J

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Type  malfunction  

Manufacturer Narrative

3 photographs were provided for evaluation in relation to the reported event.Receipt of the product was not needed to confirm the reported event.The packages contained only a filter-pro device and patient label, no syringe was present, dhr information indicates the lot met established acceptance requirements and no anomalies were noted.A quality alert was submitted to production to heighten awareness to this potential issue.Complaint information will continue to be monitored for any new information or adverse trends and further actions will be taken accordingly.Root cause was unable to be determined due to the nature of the reported event.

Event Description

It was reported that, before opening the package, the customer noticed no product was enclosed in it.There was no patient involvement reported.

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Please disregard the initial report submitted with the mfr number: 3012307300-2022-04385.The report was submitted in error.

• Brand Name: PRO-VENT SHARPS SAFETY
• Type of Device: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS,
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): NULL; 10 bowman dr.; keene NH 03431
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 4-1-5, izumi-chuo, izumi-ku,; minneapolis, MN 55442
• MDR Report Key: 13694828
• MDR Text Key: 287009541
• Report Number: 3012307300-2022-04385
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K952516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/13/2023
• Device Catalogue Number: G1463J
• Device Lot Number: 4052780
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1