MAUDE Adverse Event Report: BD CARIBE LTD. BD¿ BULK NON-STERILE CATHETER CONNECTOR; ANESTHESIA CONDUCTION KIT

Catalog Number 400145

Device Problems Complete Blockage (1094); Material Twisted/Bent (2981)

Patient Problem Discomfort (2330)

Event Date 08/29/2023

Event Type  malfunction  

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.

Event Description

It was reported that the edge of the bd¿ bulk non-sterile catheter connector had been bent back and severed the catheter during use, keeping the medication from entering the patient.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "i placed an epidural catheter without incident.When attempting to do the test dose i was unable to administer any fluid through the catheter.After adjusting and attempting multiple times the catheter was removed and found to not have any patent holes for the medication administration.Another kit was opened, and a new catheter was placed.Pt tolerated the procedure and was comfortable after procedure.I again am concerned that these kits are not of a good quality." "i placed an epidural catheter without incident.The patient was comfortable for a number of hours, but later became uncomfortable.It was found that the edge of the catheter connector had been bent back onto the epidural catheter and it had severed the catheter thus medication was not getting to the patient.The edge of the connector was quite sharp.".

Manufacturer Narrative

H.6.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.The catalog 400145 was discontinued on 14apr2023.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the edge of the bd¿ bulk non-sterile catheter connector had been bent back and severed the catheter during use, keeping the medication from entering the patient.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "i placed an epidural catheter without incident.When attempting to do the test dose i was unable to administer any fluid through the catheter.After adjusting and attempting multiple times the catheter was removed and found to not have any patent holes for the medication administration.Another kit was opened, and a new catheter was placed.Pt tolerated the procedure and was comfortable after procedure.I again am concerned that these kits are not of a good quality." "i placed an epidural catheter without incident.The patient was comfortable for a number of hours, but later became uncomfortable.It was found that the edge of the catheter connector had been bent back onto the epidural catheter and it had severed the catheter thus medication was not getting to the patient.The edge of the connector was quite sharp.".

• Brand Name: BD¿ BULK NON-STERILE CATHETER CONNECTOR
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos IA
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos IA
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17749897
• MDR Text Key: 324059390
• Report Number: 2618282-2023-00072
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953790
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 400145
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1