MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX ABS LINEDRAW DRY HEPARIN; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	4041-2
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the nurse noticed several syringes the lids does not stay on.There was unknown patient involvement and there was no human harm/adverse event reported.
Additional Manufacturer Narrative
H3: other; device not returned to manufacturer.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.
Additional Manufacturer Narrative
Device evaluation: one device was received for device analysis.Service history review identified the complaint was not related to a previous service of the device within the review period.Functional testing and visual inspection performed during analysis.The customer reported complaint could not be duplicated or confirmed.The probable root cause was unable to be determined.
Event or Problem Description
Update: gcm received an email from a(b)(6) on (b)(6) 2024, informing that there are generally 3 different times that it is noticed that the cap doesn't stay on.An experienced nurse that has been dealing with this problem for years will check the cap before ever filling it with blood to check if it will stay on because they know that it might not.Another time is after the syringe has been filled with blood and a nurse tries to put the cap on and it doesn't stay.The third time is when it isn't so obvious that it isn't a great fit with the cap it will get filled and sent and the top comes off in the tube station.It always occurs during patient use.As mentioned before, sometimes it gets caught before but more frequently it results in extra blood needing to be drawn from a patient to recollect the sample.This has been a problem for years with these blood gas syringes.At various points we've done event reports and collected syringes but then it just always seems to get lost.This is why i am so appreciative of everyone's work with this.There are no other events associated with this problem.I dropped off a bunch of syringes in (b)(6)'s office a few weeks ago.(b)(6) 2024.Update: gcm received an email from (b)(6) on (b)(6) 2024, informing that the fault occurred on (b)(6) 2024.The reporter and the other rn had issues when collecting the samples that morning.They successfully sent the specimens to lab after some extra efforts to secure the lid.They also went into the supply room and tested other syringes and found the same problem.The account number is (b)(4).The outcome of the event is hopefully it can be fixed from a manufacturer level.They are not sure about lab with that type of syringe.(b)(6) 2024.

• Brand Name: PORTEX ABS LINEDRAW DRY HEPARIN
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr; keene NH 03431
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19311129
• Report Number: 1217052-2024-00020
• Device Sequence Number: 14218802
• Product Code: JKA
• UDI-Device Identifier: 20351688021448
• UDI-Public: (01)20351688021448(17)260228(10)4386682
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K952516
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2026

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: 02/28/2026
• Device Catalogue Number: 4041-2
• Device Lot Number: 4386682
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2024
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2023
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown