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	03/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cap doesn't stay on gas syringe.There was no 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
D9: date returned to mfg.: 5/30/2024.H3 and h6.Codes: updated.Received for investigation nine 1ml syringes and filter-pros loose in a plastic bag.The syringes did not arrive assembled to a filter-pro device.It could not be determined which finished good was relevant to the reported lot number as several samples with varying lot numbers were included.No original packaging was provided.The actual device used was not returned for evaluation.Based on the results of visual inspection and functional testing, the complaint could not be confirmed with the samples provided.No further action will be conducted at this time.Complaint information will continue to be monitored for any new information or adverse trends and further actions will be taken accordingly.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• 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: 19311187
• Report Number: 1217052-2024-00021
• Device Sequence Number: 12498303
• Product Code: JKA
• UDI-Device Identifier: 20351688021448
• UDI-Public: (01)20351688021448(17)260930(10)4439309
• 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): 01/02/2025

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: 09/30/2026
• Device Catalogue Number: 4041-2
• Device Lot Number: 4439309
• 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: 12/04/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2023
• 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