MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD WINGED PNK 20GA X 1.0IN; INTRAVASCULAR CATHETER

Catalog Number	381533
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an unspecified amount of bd insyte autoguard winged pnk 20ga x 1.0in's are leaking.The following information was provided by the initial reporter: "some of them will hold flow for few seconds and then randomly start leaking out blood from the tube.The batch does not connect well to the tubing and leaks a bit during the infusion.".
Additional Manufacturer Narrative
B3: the date received by manufacturer has been used for this field.H.3: a device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Correction: facility name corrected.Investigation results: the complaint of leakage or connection issues could not be confirmed from the returned samples.40 representative 20g insyte autoguard units were received in sealed packaging from lot #3214014.A gross visual inspection shows that the units are sealed and there is no physical defect on the samples.A functional test revealed no leaks or connection issues.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Investigation conclusion(s): the defects of ¿catheter defective¿ was not confirmed.Probable root cause conclusion(s): a root cause cannot be determined in the absence of a confirmed defect.

• Brand Name: BD INSYTE AUTOGUARD WINGED PNK 20GA X 1.0IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18592779
• Report Number: 1710034-2024-00043
• Device Sequence Number: 8183108
• Product Code: FOZ
• UDI-Device Identifier: 00382903815333
• UDI-Public: (01)00382903815333
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2024

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 Expiration Date: 07/31/2026
• Device Catalogue Number: 381533
• Device Lot Number: 3214014
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2024
• Supplement Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 01/27/2024
• Supplement Report FDA Received Date: 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown