MAUDE Adverse Event Report: BECTON DICKINSON BD US CATHENA 20GX1.25IN STRAIGHT BC; INTRAVASCULAR CATHETER

Catalog Number	386863
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd us cathena 20gx1.25in straight bc needle retraction failed the following information was provided by the initial reporter: it was reported by customer that we had a 20g iv malfunction earlier.When the nurse went to pull back the safety the needle wouldn¿t retract.It appears to be bent and the patient had to be stuck again because of it.I have attached pictures and saved the angio this time! i have it in my office.Verbatim: we had a 20g iv malfunction earlier.When the nurse went to pull back the safety the needle wouldn¿t retract.It appears to be bent and the patient had to be stuck again because of it.I have attached pictures and saved the angio this time! i have it in my office.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Material#: 386863 batch#: 3293975 it was reported by customer that we had a 20g iv malfunction earlier.When the nurse went to pull back the safety the needle wouldn¿t retract.It appears to be bent and the patient had to be stuck again because of it.I have attached pictures and saved the angio this time! i have it in my office.Verbatim: we had a 20g iv malfunction earlier.When the nurse went to pull back the safety the needle wouldn¿t retract.It appears to be bent and the patient had to be stuck again because of it.I have attached pictures and saved the angio this time! i have it in my office.
Additional Manufacturer Narrative
Our quality engineer inspected the photos submitted for evaluation.The reported issue of safety activation failure was confirmed upon inspection of the photos.However, bd cannot confirm the cause of the failure to our manufacturing process since no physical sample was returned.We would be very interested in examining product that does not meet your expectations and our quality standards.Examination of the actual product involved may provide clarification as to the cause of the reported failure.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.Current controls include a daily functional test and a two-hourly in-process functional test to check and detect safety activation failure.

• Brand Name: BD US CATHENA 20GX1.25IN STRAIGHT BC
• Common Device Name: INTRAVASCULAR CATHETER
• 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: 18888729
• Report Number: 2243072-2024-00276
• Device Sequence Number: 16893408
• Product Code: FOZ
• UDI-Device Identifier: 00382903868636
• UDI-Public: (01)00382903868636
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K220584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2024

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: Other
• Device Expiration Date: 09/30/2026
• Device Catalogue Number: 386863
• Device Lot Number: 3293975
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2024
• Supplement Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown