MAUDE Adverse Event Report: BECTON DICKINSON BD INSYTE YEL 22GA X 1IN; INTRAVASCULAR CATHETER

Catalog Number	381223
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd insyte yel 22ga x 1in leaked at catheter junction the following information was provided by the initial reporter: as discussed with on the phone, we have had 2 problems with insyte catheters over the past 2 days.The first was a 24ga 0.75in that had a jagged edge on the tip so you could not use or place the catheter.I thought it was a once off so threw it away.I have attached the batch details anyway.I have no idea if other catheters in this batch are affected as we rarely use that size.This morning we used a 22ga 1 " insyte catheter which was leaking between the sheath and the hub.See pic and batch details.These catheters were from our order yesterday.
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
As discussed with xxxx on the phone, we have had 2 problems with insyte catheters over the past 2 days.The first was a 24ga 0.75in that had a jagged edge on the tip so you could not use or place the catheter.I thought it was a once off so threw it away.I have attached the batch details anyway.I have no idea if other catheters in this batch are affected as we rarely use that size.This morning we used a 22ga 1 " insyte catheter which was leaking between the sheath and the hub.See pic and batch details.These catheters were from our order yesterday.
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of the affected batch.From the actual sample that failed leak test, a ¿v¿ cut was observed on the catheter tubing near the nose of adapter that matches the shape of the bevel, which could be caused by needle pierced through catheter.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.As the sample was used, actual root cause could not be established.As current controls, there are outgoing and hourly in-process visual inspections in place to check for catheter tubing damage.There is also a daily outgoing functional test in place to check for catheter leakage.

• Brand Name: BD INSYTE YEL 22GA X 1IN
• 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: 18400448
• Report Number: 2243072-2023-02244
• Device Sequence Number: 4072547
• Product Code: FOZ
• UDI-Device Identifier: 30382903812234
• UDI-Public: (01)30382903812234
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 02/20/2024

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: 381223
• Device Lot Number: 3177848
• 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: 11/30/2023
• Supplement Date Received by Manufacturer: 02/20/2024
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2023
• 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