MAUDE Adverse Event Report: BECTON DICKINSON BD INSYTE PNK 20GA X 1.16IN; INTRAVASCULAR CATHETER

Catalog Number	381234
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
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 pnk 20ga x 1.16in leakage at catheter junction.When connecting the infusion to the catheter hub, leakage occurs at the connection.As a result, the catheter must be reinserted.
Event or Problem Description
When connecting the infusion to the catheter hub, leakage occurs at the connection.As a result, the catheter must be reinserted.
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of the reported batch.The returned samples passed the catheter leak test; however, sample#1 a dent was observed on the adapter inner luer.The assembly process was reviewed, the dent was suspected to be caused by adapter contacted by the gripper at the tipper station due to misalignment.(b)(4).As current control, there is an outgoing functional test in place to check for catheter adapter leakage.There is also in-process visual inspection in place to check for catheter adapter damage which could cause leakage.Communication was conducted for the split tubing and inner luer dent defect: communication to inyste tipper line production technician to monitor the occurrence of the adapter inner luer dent defect completed.

• Brand Name: BD INSYTE PNK 20GA X 1.16IN
• 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: 20239071
• Report Number: 2243072-2024-00974
• Device Sequence Number: 20999381
• Product Code: FOZ
• UDI-Device Identifier: 00382903812349
• UDI-Public: (01)00382903812349(11)240425(17)290331(10)4116678
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 10/07/2024

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: 381234
• Device Lot Number: 4116678
• 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: 08/22/2024
• Supplement Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown