MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX ABS PRO-VENT; SYRINGE, ANTISTICK

Catalog Number G1459J

Device Problems Break (1069); Leak/Splash (1354)

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

Event Date 02/01/2023

Event Type  malfunction  

Manufacturer Narrative

Month and year of event have been provided; day is unknown.Udi number is unknown; no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that during the use of the product, leakage of blood sample from the damaged (or broken) part was observed.No patient injury was reported.

Manufacturer Narrative

Other, other text: manufacturing report number 3012307300-2023-02436 was submitted in error.After further review, the malfunction reported is not likely to cause or contribute to death or serious injury and there is no evidence of a reportable product malfunction.The hazardous situation for the given complaint device would not likely cause or contribute to a death or serious injury if the malfunction were to recur.This complaint file is considered not reportable, please disregard any reports associated with it.

• Brand Name: PORTEX ABS PRO-VENT
• Type of Device: SYRINGE, ANTISTICK
• 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; 7-1-1 akasaka; minneapolis, MN 55442
• MDR Report Key: 16541823
• MDR Text Key: 311291707
• Report Number: 3012307300-2023-02436
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063755
• 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: 04/28/2023

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 Operator: Health Professional
• Device Catalogue Number: G1459J
• Device Lot Number: 4351955
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/24/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/20/2023
• Initial Date FDA Received: 03/14/2023
• Supplement Dates Manufacturer Received: 03/29/2023
• Supplement Dates FDA Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1