MAUDE Adverse Event Report: BECTON DICKINSON INSYTE AUTOG BC WING PNK 20GA X1.16IN; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number	382634
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material: 382634.Batch#: 4172507.It was reported by the customer that when advanced, the catheter section split apart from the needle.No patient harm.
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: no photos or physical samples that display the reported condition were available for investigation.A device history record review was completed by our quality engineer team for provided material number 382634 and lot number 4172507.A quality notification related to the reported defect was initiated during the build of this lot, however without a sample we cannot confirm that this failure was related to that notification.Based on the available information, an exact cause for this incident could not be identified.

• Brand Name: INSYTE AUTOG BC WING PNK 20GA X1.16IN
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• 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: 20912999
• Report Number: 1710034-2024-01478
• Device Sequence Number: 7825532
• Product Code: FOZ
• UDI-Device Identifier: 00382903826346
• UDI-Public: (01)00382903826346(11)240620(17)270430(10)4172507
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2025

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: 382634
• Device Lot Number: 4172507
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2024
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown