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

Catalog Number	G1469J
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.Reason device not evaluated by mfg: other; device was 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.
Event or Problem Description
It was reported that blood leaked to the tip of the filter pro.There was no disinfection or sterilization, and no infectious disease occurred.This occurred during patient use, and there was no patient harm/adverse event reported.
Additional Manufacturer Narrative
H6.Codes: updated.Device evaluation: no product was returned for investigation.Three pictures were provided showing the customer's reported issue.One photo shows a side-by side comparison after a blood collection.The filter-pro device on the left shows that leakage extended past the acceptable fluid penetration depth of.060".In-process, filter-pro devices are automatically assembled and glued from supplied components.The maintenance log review found no entries relevant to the reported problem on the date of manufacture.The lot acceptance is based on c=0 (critical) visual inspection for damages, that affect function and device history record (dhr) information indicates the lot met the established acceptance requirements.While the allegation was confirmed, it could not be stated with confidence whether the area was damaged, had a short fill or was not properly sealed.Without the device, the exact problem source for the compromised filter-pro could not be identified.

• Brand Name: PORTEX LINEDRAW DRY HEPARIN ARTERIAL BLOOD SAMPLING KIT
• 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20798118
• Report Number: 1217052-2024-00207
• Device Sequence Number: 20781337
• Product Code: JKA
• UDI-Device Identifier: 00351688060238
• UDI-Public: (01)00351688060238(17)270306(10)4467041
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2025

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 Catalogue Number: G1469J
• Device Lot Number: 4467041
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2024
• 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