MAUDE Adverse Event Report: BD SUZHOU (MDS) INSYTE; INTRAVASCULAR CATHETER

Catalog Number	381237
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd insyte pnk 20ga x 1.88in leaked entry description of (b)(6): on (b)(6) 2025, a nurse discovered leakage at the connection point after priming a syringe.Approximately five syringes of this model were found to be defective in the box.During use of this product, loose connections caused leakage; one unit affected; sample can be returned with photos provided; requires green claims processing; requires complaint response letter; requires complaint receipt letter.
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 photo and sample submitted for evaluation.The reported issue of leakage at adapter tubing was not confirmed upon inspection of the sample.However, adapter/ connector defective/ damaged was confirmed.Analysis of the sample showed a minor dent on the catheter adapter inner luer.The sample was subjected to a catheter leak test and the sample passed with no abnormalities observed.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.The assembly process was reviewed.The dent was suspected to be caused by the pick and place tool.It was loose and hit the luer area when picking the adapter from the pallet.Corrective action was taken to prevent the inner luer dent defect.A monthly preventative maintenance task was added to check if the picker rod end is worn off and replace as needed.The reported lot was manufactured before the action implementation.

• Brand Name: INSYTE
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD SUZHOU (MDS); #5 baiyu road; suzhou industrial park; jiangsu 21502 1; CH 215021
• 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: 23999509
• Report Number: 2243072-2025-01564
• Device Sequence Number: 10503613
• Product Code: FOZ
• UDI-Device Identifier: 00382903812370
• UDI-Public: (01)00382903812370
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2026

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: 381237
• Device Lot Number: 5008240
• 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: 12/19/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 01/23/2026
• 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
• Patient Sex: Unknown