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

Catalog Number	381323
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/13/2023
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-w winged bl 22ga x 1.0in needle went through catheter the following information was provided by the initial reporter; we received the following complaint from ref (b)(4) insyte w ailettes peripheral intravenous catheter 22g1" 0.9x25 mm : after pricking the patient and withdrawing the needle, the needle splits in two.This is life-threatening for the patient.(see photo attached).Lot number : 1321240 which procedure should we follow please ?.
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of the affected batch.From the returned photos, needle pierced through catheter was observed.The assembly process was reviewed.If the needle pierced through catheter occurred in the manufacturing process, the defect would be detected and auto rejected by the 100% inline tip spear vision inspection system.Needle pierced through catheter could happen during product application when the product was manipulated, or during needle cover removal if not done carefully.As current control, there is outgoing inspection and hourly in-process inspection in place to check for needle pierced through catheter and catheter damage.
Event or Problem Description
We received the following complaint from ref (b)(4) insyte w ailettes peripheral intravenous catheter 22g1" 0.9x25 mm : after pricking the patient and withdrawing the needle, the needle splits in two.This is life-threatening for the patient.(see photo attached).Lot number : 1321240 which procedure should we follow please ?.

• Brand Name: BD INSYTE-W WINGED 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
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18276277
• Report Number: 2243072-2023-02147
• Device Sequence Number: 6936419
• Product Code: FOZ
• UDI-Device Identifier: 30382903813231
• UDI-Public: (01)30382903813231
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 01/29/2024

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 Catalogue Number: 381323
• Device Lot Number: 1321240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2023
• Supplement Date Received by Manufacturer: 01/29/2024
• Initial Report FDA Received Date: 12/06/2023
• Supplement Report FDA Received Date: 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown