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

Model Number	4909E
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4) as a result of warning letter cms# (b)(4).A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.The device was received for evaluation.Visual and functional testing were performed.Visual inspection revealed that the catheter and connector were not assembled.The catheter was loose within the bag.The connector was in the fully engaged position (closed) upon receipt.During the dimensional evaluation, all samples were found to be within specification.The returned sample was tested as an assembly (catheter to a detachable hub).The assembly failed to remain assembled when tested with 5n weight.While consideration may be made to account for the condition of the used samples prior to testing, the separation of the components confirmed the complaint.However, the root cause of the issue could not be determined.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken.
Event or Problem Description
It was reported that there was an epidural disconnect with the new individually-packaged connectors.No patient injury was reported.

• Brand Name: PORTEX EPIDURAL CONNECTORS
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15591064
• Report Number: 3012307300-2022-23563
• Device Sequence Number: 17736528
• Product Code: CAZ
• UDI-Device Identifier: 10351688076083
• UDI-Public: 10351688076083
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K092657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/12/2022

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: 05/02/2024
• Device Model Number: 4909E
• Device Catalogue Number: 4909E
• Device Lot Number: 3813919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2022
• Initial Report FDA Received Date: 10/12/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Hispanic