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

Catalog Number	386806
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd cathena leaked past the bc valve.The following information was provided by the initial reporter: it did not stop bleeding as it is suppose to and she could not attach a iv bang either.We had to remove it unfortunately and re insert a new one using old canula.
Additional Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.E1.Address information was not provided, therefore, xx was used as a place holder.In this mdr, bd franklin lakes, nj has been listed in sections d.3.And g.1.
Additional Manufacturer Narrative
Batch number is unavailable and hence unable to perform the dhr review of the affected batch.Current control there is a daily blood escape time (bet) functional test that can blood control components damage which can cause leakage at the septum (blood control valve).As no actual sample is returned for evaluation, root cause could not be established.
Event or Problem Description
Email description from customer: it did not stop bleeding as it is suppose to and she could not attach a iv bang either.We had to remove it unfortunately and re insert a new one using old canula.

• Brand Name: BD CATHENA
• Common Device Name: PERIPHERAL IV CATHETERS
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19015299
• Report Number: 2243072-2024-00484
• Device Sequence Number: 3809660
• Product Code: FOZ
• UDI-Device Identifier: 00382903868063
• UDI-Public: (01)00382903868063
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K220584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 386806
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2024
• Supplement Date Received by Manufacturer: 04/26/2024
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown