MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX PRO-VENT, LINE DRAW, PULSATOR; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COL

Model Number	4041E
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event problem and evaluation codes: updated a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product sample nor photos were received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that the blood gas syringe has a crack in the middle, blood is leaking out.No patient injury was reported.

• Brand Name: PORTEX PRO-VENT, LINE DRAW, PULSATOR
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COL
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16694302
• Report Number: 3012307300-2023-03712
• Device Sequence Number: 14972536
• Product Code: JKA
• UDI-Device Identifier: 20351688039177
• UDI-Public: 20351688039177
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K952516
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/06/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/23/2023
• Device Model Number: 4041E
• Device Catalogue Number: 4041E
• Device Lot Number: 3984749
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown