MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD; PERIPHERAL IV CATHETER

Catalog Number	381833
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2023
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 autoguard has foreign matter inside the cap.The following information was provided by the initial reporter: 1.Please describe the specific issue found on defective product? black specs noted inside the cap of the needle upon opening a new angiocath 2.How was the patient outcome? are there any clinical signs, health consequences or impact? no impact to patient, the product was switched to a new angiocath after careful inspection.3.Any adverse event or serious injury reported to patient or health care professional? no 4.Are you able to provide the dates of the events in the format of mm-dd-yyyy? if unknown, can state unknown.(b)(6) 2023.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: the complaint of black specs on the device was confirmed and the cause appeared to be manufacturing related.Three photographs of a 20g insyte autoguard unit show black spots on the barrel, which were consistent with burnt resin that become embedded within the molded part.If the foreign matter is embedded in the device, this defect most likely occurred during the molding process.During molding, resin is used to form the device.It¿s possible that previous resin got burnt and was still present when this device was in the molding process, causing the black solid foreign matter.The appropriate manufacturing personnel were notified of this complaint.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 defect of ¿foreign matter¿ was confirmed.Probable root cause(s): manufacturing/molding.

• Brand Name: BD INSYTE AUTOGUARD
• Common Device Name: PERIPHERAL IV 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: 18279662
• Report Number: 1710034-2023-01405
• Device Sequence Number: 17653205
• Product Code: FOZ
• UDI-Device Identifier: 00382903818334
• UDI-Public: (01)00382903818334
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: 505
• 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: Other
• Device Expiration Date: 02/28/2026
• Device Catalogue Number: 381833
• Device Lot Number: 3055420
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 12/06/2023
• Supplement Report FDA Received Date: 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown