MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AG BC GLOBAL WING; PERIPHERAL IV CATHETERS

Catalog Number	382923
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
It was reported that bd insyte ag bc global wing had "foreign matter - component fragments/plastic".Due to the excess plastic on the thread of the catheter, the adapter/connector did not properly secure.The following information was provided by the initial reporter, translated from french to english: a lack of adaptation was noted by several mers.The problem disappeared with the change of batch of catheters in stock in the service.None of the catheters were preserved.From ansam report: current patient condition: risk of aes infectious risk for the patient.Actions taken in the healthcare establishment for patient care: change of equipment none of the catheters were kept the problem disappeared with the change of batch of catheters in stock in the department 28 nov 2023 customer response: i have just received the response from the service manager.She writes: there was a plastic 'little lip' on the thread of the catheter preventing the fitting from being screwed in properly.As a result, this created an air ingress and a leak at the screw thread.
Additional Manufacturer Narrative
Investigation results: 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.
Event or Problem Description
No additional information.

• Brand Name: BD INSYTE AG BC GLOBAL WING
• Common Device Name: PERIPHERAL IV CATHETERS
• 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: 18270887
• Report Number: 1710034-2023-01389
• Device Sequence Number: 3954325
• Product Code: FOZ
• UDI-Device Identifier: 00382903829231
• UDI-Public: (01)00382903829231
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: UKN
• 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): 02/27/2024

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: 05/31/2026
• Device Catalogue Number: 382923
• Device Lot Number: 3166525
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2023
• Supplement Date Received by Manufacturer: 02/27/2024
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown