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

Catalog Number A4219-17

Device Problem Disconnection (1171)

Patient Problem Pain (1994)

Event Date 01/30/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluation in progress.

Event Description

It was reported that the epidural catheter tubing became disconnected from the yellow hub.The epidural had to be discontinued as a result, and the patient experienced quite a bit of pain before the symptoms were subsequently controlled.No patient injury or further complications were reported in relation to this event.

Manufacturer Narrative

H6: event problem and evaluation codes: updated after device evaluation.H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Received for investigation one epifuse connector (cp1690) and one catheter (ca046), decontaminated.As received the catheter is separated from the connector confirming the allegation.Component part numbers were established based on the components of the complaint product kit a4219-17, referenced in this complaint.The connector was received in the closed condition as it would be during use.There is no visual abnormality observed of connector in its closed condition.The catheter tubing was found to be somewhat kinked/bent along its length, particularly from the distal tip to the 150mm graduation.There is an observable substance on the catheter toward the proximal end in an area just distal to the proximal mark, which is the area immediately distal to where the connector (cp1690) is attached during use.Based on the bent nature of the catheter, the distance from the distal tip to the 150mm graduation mark was measured by a mm ruler and found somewhat elongated as maybe expected due to removal of the catheter from the patient.The connector was opened.No visual abnormalities were observed.As expected, the clamping features of the hard plastic shell of the connector had left obvious compression marks on the blue colored sleeve into which the catheter is inserted.While complaint allegation was confirmed based on the condition of returned components, however a specific cause for customer reported difficulties could not be determined.The reported by the customer difficulties could not be replicated during retention test of the returned catheter component.The returned catheter met the retention requirement when tested with connector from stock.The cause of the reported problem could not be determined.No lot number was provided and dhr review could not be performed to specifically determine the catheter and connector lots involved in this complaint.

• Brand Name: PORTEX EPIDURAL CUSTOM CONTINUOUS TRAYS
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): NULL; 10 bowman dr.; keene NH 03431
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11664027
• MDR Text Key: 245357293
• Report Number: 3012307300-2021-03102
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: A4219-17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1