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

Catalog Number 381823

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/25/2023

Event Type  malfunction  

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 Description

It was reported that bd insyte autoguard rust noted in the safety barrel.The following information was provided by the initial reporter, translated from spanish to english: the medical device is dispensed and when they uncover the packaging, they realize that the device had a dark color on the transparent part that looked like rust.They approach the pharmacy where the device is checked and it is evidently in accordance with what was referenced by nurse personnel.Impact to patient: none.Another device was used.Additional information received on 14.Dec.2023: there was no damage to patient/professional.

Manufacturer Narrative

Investigation results: received a report containing 3 photos of an unsealed retracted 22ga x 1.00in.Insyte autoguard unit.Visual inspection cannot confirm that there is rust or corrosion, but the grip does have discoloration.The reported defect was confirmed.During manufacturing discoloration to the grip can result from too high of ultraviolet radiation (uv) dosage due to excess time in the uv oven.Per the quality control plan controlled visual inspections are conducted and machine software is controlled to mitigate this type of defect occurrence.Normally, if this was the cause of the defect then the needle hub and the button would also have some discoloration.Only the grip was discolored.Another possibility is this occurred during molding.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 dark solid matter embedded to the grip.Quality control plan visual inspection, environmental monitoring, and gowning are performed to mitigate the occurrence of this defect.Investigation conclusion(s): the defect of ¿discolored¿ was confirmed.Probable root cause(s): molding.

Event Description

No additional information.

• Brand Name: BD INSYTE AUTOGUARD
• Type of Device: 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: 18374644
• MDR Text Key: 331380343
• Report Number: 1710034-2023-01473
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818235
• UDI-Public: (01)00382903818235
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/29/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 381823
• Device Lot Number: 2335742
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2023
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 01/29/2024
• Supplement Dates FDA Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1