MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX CONTINUOUS EPIDURAL TRAY; CATHETER, CONDUCTION, ANESTHETIC

Catalog Number	24-1300-22
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2024
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 the slightest overtightening of the filter leads to a disconnection and the need to open a new pack.There was patient involvement, but no patient harm/adverse event reported.There were multiple devices affected.
Additional Manufacturer Narrative
One used decontaminated sample was received for investigation.Received flat filter with rotating hub that was assembled 5 times with received epifuse connector and after overtightening of the filter the disconnection appeared each time.As per the ifu, overtightening the connection between the epidural catheter connector or epidural needle to the male rotating collar may cause rotating collar to dislodge from filter body.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: PORTEX CONTINUOUS EPIDURAL TRAY
• Common Device Name: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19221861
• Report Number: 3012307300-2024-03223
• Device Sequence Number: 6942307
• Product Code: BSO
• UDI-Device Identifier: 15019517075335
• UDI-Public: (01)15019517075335(17)280110(10)4321274
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K062005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2024

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: 24-1300-22
• Device Lot Number: 4321274
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/29/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2024
• Supplement Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2023
• 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