MAUDE Adverse Event Report: BD CARIBE LTD. BD KIT PERISAFE 18GA 3-1/2IN WEISS ANESTHESIA CONDUCTION KIT

Model Number 400273

Device Problem Break (1069)

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

Event Date 11/17/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported when using the bd kit perisafe 18ga 3-1/2in weiss the catheter broke apart. The following information was provided by the initial reporter. The customer stated: "when the anesthesiologist inserted perisafe in the patient and while removing the epidural needle, the tip of the epidural catheter got cut around 1 cm. The dr was suspecting the tip of the epidural catheter remains in the patient while removing it. However post operation, they will perform a xray and ct scan. " no further information provided at this time.

• Brand Name: BD KIT PERISAFE 18GA 3-1/2IN WEISS
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13006333
• MDR Text Key: 284838370
• Report Number: 2618282-2021-00077
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K953790
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/27/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 400273
• Device Catalogue Number: 400273
• Device Lot Number: 0302097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial