MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX SINGLE SHOT EPIDURAL KIT; ANESTHESIA CONDUCTION KIT

Catalog Number	A4032-18
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 there was an epidural tray with a broken saline vial.The vial was empty, and they could feel a residue on the clear drape, likely dried saline.There was no patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
D9.Date returned to mfg: 04-nov-2024.H6.Investigation codes: updated.Investigation summary: received for investigation one opened single shot epidural tray product # a4032-18, lot # 4447076.The tyvek lid was taped shut with scotch tape.The tray was examined, and it was observed that the contents were in disarray.The saline vial had a broken neck.In process, the kits are manually filled utilizing a tray with molded compartments specific to each component.In principle, this design is to maintain the integrity of the contents during transport.The breakage of glass components could possibly occur during shipment when the cartons are not handled with care.(smiths cartons are marked "fragile" and "contains glass" to prevent breakages).Based on the evaluation of the returned product and investigation results, the complaint for broken vials was confirmed.No action will be conducted at this time.Complaint information will continue to be monitored for any new information or adverse trends and take further actions accordingly.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: PORTEX SINGLE SHOT EPIDURAL KIT
• Common Device Name: ANESTHESIA CONDUCTION KIT
• 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: 20304724
• Report Number: 1217052-2024-00117
• Device Sequence Number: 18048339
• Product Code: CAZ
• UDI-Device Identifier: 20351688080247
• UDI-Public: (01)20351688080247(17)251101(10)4447076
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K965017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2025

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: 11/01/2025
• Device Catalogue Number: A4032-18
• Device Lot Number: 4447076
• 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: 09/05/2024
• Supplement Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2023
• 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