MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX ARTERIAL BLOOD SAMPLING KITS; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COL

Catalog Number 4590PG

Device Problems Obstruction of Flow (2423); Defective Device (2588)

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

Event Type  malfunction  

Event Description

It was reported that the suspect device was defective due to its inability to aspirate: no patient injury was reported.

Manufacturer Narrative

A device history record (dhr) review was conducted which indicated all inspection were completed and no issues were noted during manufacture.The original suspect device was not received in the manufacturing for evaluation; however, an unopened original package was received sent by the customer.The returned sample was evaluated and preformed functional testing in several different scenarios which the returned sample passed all functional testing.The issue that was reported by the customer could not be duplicated with the returned sample, therefore, the complaint could not be confirmed.Will continue to monitor any new information and will take actions accordingly.No problem found based on the provided sample.Udi # is unknown.No information is provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX ARTERIAL BLOOD SAMPLING KITS
• Type of Device: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COL
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15321926
• MDR Text Key: 305424685
• Report Number: 3012307300-2022-16802
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K952516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2023
• Device Catalogue Number: 4590PG
• Device Lot Number: 3968638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female