MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX KIDS KIT CLOSED BLOOD SAMPLING SYSTEM; PROBE, BLOOD-FLOW, EXTRAVASCULAR

Catalog Number MX4137

Device Problem Air/Gas in Device (4062)

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

Event Type  malfunction  

Manufacturer Narrative

A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Product samples were received for evaluation.Visual and functional testing were performed.Six (6) used samples outside its original package received for investigation.One sample could not get blood out of intravenous (iv) site.Photo is attached for investigation.Returned sample were visually inspected by quality engineer, according to procedure.It was observed on one returned sample came in out of the part and loose during decontamination process.As one sample did not have the part number.Only five (5) of returned samples were tested for water leak test according procedures.The results found no leakages were observed on the returned samples and no bubbles or air were noted on the syringe used to test the five (5) samples.The root cause of the reported issue could not be confirmed.An awareness meeting with operators and quality inspectors about the failure mode reported on this complaint was held and documented.Unique identifier are unknown.No information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.

Event Description

It was reported that when a specimen was being obtained through the sample port, air was noted in syringe.All the connections were tight.The reporter was notified of the reported issue on three (3) different patients, unsure of day.Additional four (4) more reports were received by reporter.No patient injury was reported.

• Brand Name: MEDEX KIDS KIT CLOSED BLOOD SAMPLING SYSTEM
• Type of Device: PROBE, BLOOD-FLOW, EXTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16632769
• MDR Text Key: 312235034
• Report Number: 3012307300-2023-03156
• Device Sequence Number: 1
• Product Code: DPT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/11/2023
• Device Catalogue Number: MX4137
• Device Lot Number: 3906159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Was the Report Sent to FDA?: No
• 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