MAUDE Adverse Event Report: BECTON DICKINSON BD INSYTE BL 22GA X 1.0IN; INTRAVASCULAR CATHETER

Catalog Number	381223
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2024
Type of Reportable Event	Malfunction
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
It was reported that bd insyte bl 22ga x 1.0in adapter / connector / hub - not able to connect to mating component the following information was provided by the initial reporter: this complaint came through tga; patient requires re cannulation or multiple cannulations.Stock with batch number batch n#3237898.Removed from circulation.Internal hospital s1 product complaint form submitted.Additional event description: anaesthetist cannulated patient successfully.When needle removed and bung attached the bund was not able to be tightened (multiple bungs tried) the cannula was removed and patient required re canulation.Canula deemed to be faulty.Several patient's same outcome see attached - dir 94964.
Event or Problem Description
This complaint came through tga; patient requires re cannulation or multiple cannulations.Stock with batch number batch n#3237898.Removed from circulation.Internal hospital s1 product complaint form submitted.Additional event description: anesthetist cannulated patient successfully.When needle removed and bung attached the bund was not able to be tightened (multiple bungs tried) the cannula was removed and patient required re canulation.Canula deemed to be faulty.Several patient's same outcome see attached - (b)(4).
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of the affected batch.As current control, there is outgoing inspection and hourly in-process inspection in place to check for damaged components.As no photo/sample was received for further investigation, root cause could not be determined.The complaint will be re-opened and re-investigated when photo/sample is received.

• Brand Name: BD INSYTE BL 22GA X 1.0IN
• 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: 19006472
• Report Number: 2243072-2024-00475
• Device Sequence Number: 18254283
• Product Code: FOZ
• UDI-Device Identifier: 00382903812233
• UDI-Public: (01)00382903812233
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2024

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: 381223
• Device Lot Number: 3237898
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2024
• Supplement Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown