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

Catalog Number	381223
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Infliximab dose 1 iv inserted by rn, two attempts.On completion of infusion some pain and bleeding at site.As per protocol needed two hours observation, iv blood withdrew and flushed, appeared patent, no further pain.Two hours later on discharge all obs stable, iv removed.When removing cannula, it appeared to still be intact, upon pulling the cannula out a "suction" sound was heard and felt, and it was observed that part of the cannula tip was missing.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Our quality engineer inspected the 2 samples submitted for evaluation.The reported issue of catheter broke/ separated after placement was confirmed upon inspection of the samples.Analysis of the samples showed the catheter broken on the first sample.The point of breakage had jagged edges and stress marks.A v cut was observed near the breakage point.No damage or defects were observed on the second sample.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records have been reviewed, and this batch meets our manufacturing specification requirements.From the returned sample, it was observed that the catheter tubing broke off into 2 fragments from the nose of the adapter.One of the fragments of tubing had a v-cut, near the edge of the break point.This suggests that the pierce through the catheter occurred first, then later the sample was pulled, causing the final breakage.The assembly process was reviewed.If the needle pierced through the catheter during the manufacturing process, the defect would be detected and auto rejected by the 100% inline tip spear vision inspection system.Needles can pierce through the catheter during product application, when the product is manipulated, or during needle cover removal if not done carefully.The root cause for the leak was unable to be identified, as no leakage was detected on the returned sample.

• Brand Name: 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
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23481724
• Report Number: 2243072-2025-01356
• Device Sequence Number: 16009496
• Product Code: FOZ
• UDI-Device Identifier: 00382903812233
• UDI-Public: (01)00382903812233(10)5163186
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 12/01/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 381223
• Device Lot Number: 5163186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 12/02/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown