MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX PRO-VENT 3ML NEEDLE; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	G1463J
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Date of event: month and year of event have been provided, but day is unknown.D4.Primary udi number: the primary di# has been used as the lot/serial information is unknown.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 the syringe part was damaged during use.There was patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
Investigation summary: received for investigation, one used, decontaminated 3ml syringe.Pictures were also provided.No identifying package material was included, customer stated it was product g1463 unknown lot #.Visual inspection of the returned sample showed damage near the shoulder of the barrel, thus complaint confirmation.The condition of the product was such that it was not possible to conduct a leak test.While the complaint is confirmed, without a provided lot number, it cannot be determined what machine the product was packaged/assembled on or how the defect occurred.No further actions will be taken 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 could not be completed as no lot number was received.

• Brand Name: PORTEX PRO-VENT 3ML NEEDLE
• 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: 20652111
• Report Number: 1217052-2024-00181
• Device Sequence Number: 8219097
• Product Code: JKA
• UDI-Device Identifier: 00351688060177
• UDI-Public: (01)00351688060177
• 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): 12/05/2024

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: G1463J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2024
• Supplement Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 11/11/2024
• Supplement Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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