MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. ANESTHESIA CONNECTOR DOUBLE SWIVEL; CONNECTOR, AIRWAY (EXTENSION)

Catalog Number 100/255/150

Device Problems Misconnection (1399); Failure to Disconnect (2541)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/12/2023

Event Type  malfunction  

Event Description

It was reported that the customer had mistakenly connected the double swivel connector to an endoscope.Attempted to disconnect them, but could not and a new product was used.It was reported that there was no patient injury and no additional information is available for this complaint.

Manufacturer Narrative

Lot number, expiration date, udi number, device manufacture date are unknown, no information has been provided to date.G5: 510k is blank device is exempt.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.

Manufacturer Narrative

One device without the original packaging inside a plastic bag was received.Visual inspection: with an un-aided eye it was observed that the device had a part inserted in the swivel connector.The part was removed with no difficulty.It was seen that the part inserted is not a component of the finished good.The complaint was not confirmed as the extraneous material could be removed easily additionally the device was acceptable for luer insertion test.A device history record (dhr) review could not be performed as the lot number was unknown.No action taken as the complaint could not be confirmed with returned device as it was found within specification for luer insertion.

• Brand Name: ANESTHESIA CONNECTOR DOUBLE SWIVEL
• Type of Device: CONNECTOR, AIRWAY (EXTENSION)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16834430
• MDR Text Key: 314210590
• Report Number: 3012307300-2023-04735
• Device Sequence Number: 1
• Product Code: BZA
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/255/150
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/18/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1