MAUDE Adverse Event Report: BECTON DICKINSON BD CATHINA; PERIPHERAL IV CATHETERS

Catalog Number UNKNOWN

Device Problem Retraction Problem (1536)

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

Event Date 03/21/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

Event Description

It was reported that bd cathina safety did not engage.The following information was provided by the initial reporter: i wanted to make you aware we had another iv today where the needle is bent and the safety will not engage.This time it was an 18g iv.

Event Description

Material #: unknown, batch#: 3293975.It was reported by customer that they had another iv today where the needle is bent, and the safety will not engage.Verbatim: i wanted to make you aware we had another iv today where the needle is bent and the safety will not engage.This time it was an 18g iv.Customer response for follow-up: (b)(6) took the angios to be processed when she was on site a few weeks ago so i do not have info for 1 & 2.One patient required a second iv stick d/t the occurrence.No other issues occurred we had 2 confirmed occurrences of the safety not engaging.(b)(6).

Manufacturer Narrative

Needle bent.No bent cannula observed on returned actual samples.As current control, there is a 100% vision inspection system for lie distance, which is also able to fail and reject needle bent parts due to out of the camera scope.Safety shield activation failure (catheter) the safety mechanism of the returned sample was able to be manually activated; no safety activation failure was observed.As current control, there are outgoing functional test and 2-hourly in-process functional test to check and detect safety activation failure.

• Brand Name: BD CATHINA
• Type of Device: PERIPHERAL IV CATHETERS
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19110567
• MDR Text Key: 340907721
• Report Number: 2243072-2024-00546
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/04/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1