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

Catalog Number	381034
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd insyte autog bc global foreign matter the following information was provided by the initial reporter, translated from japanese to english: this is a report about fm in the needle.Although it has not yet been opened, there are black spots on the indwelling needle.
Additional Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the sample and photographs submitted for evaluation.Bd received 5 photos and one unit of a 20gx1.00in insyte autoguard from lot number 3228127.Your report of black spots in the molded grip component was confirmed.This was physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect.The material was determined to be burnt particulate resin (non-foreign).The black specks were most likely created as part of the molding process.Burnt imbedded resin specks result from material build up in the barrel/screw.A device history record review showed no non-conformances associated with this issue during the production of this batch.
Event or Problem Description
No additional information.

• Brand Name: BD INSYTE AUTOG BC GLOBAL
• 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: 20896173
• Report Number: 1710034-2024-01465
• Device Sequence Number: 9043721
• Product Code: FOZ
• UDI-Device Identifier: 00382903810345
• UDI-Public: (01)00382903810345
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2025

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: Other
• Device Expiration Date: 07/31/2026
• Device Catalogue Number: 381034
• Device Lot Number: 3228127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2024
• Supplement Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown