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

Catalog Number 381023

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

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

Event Date 10/06/2023

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.B3.The date received by manufacturer has been used for this field.

Event Description

It was reported that bd insyte autog bc has foreign matter on its tip.The following information was provided by the initial reporter, translated from french to english: i have received a materiovigilance report on a catheter which has a metallic debris on its tip.Has the patient suffered any clinical consequences due to this defect? no.

Event Description

Additional information: could you specify the date of the event? 06/10/2023 at 16:00.

Manufacturer Narrative

Additional information: event date received from customer and updated in b3.Investigation results: received one photo and one opened unit of a 22gx1.00in insyte autoguard device from lot 3045823 for the investigation of this complaint.The photo shows a spec of material on the catheter near the tip.A gross visual inspection of the physical sample shows a small dark spec of foreign material loose in the needle cover.The material has an uneven and rough surface.The edges of the foreign material are uneven.Upon handling of the foreign material, it was identified that the foreign matter is more flexible than hard or brittle and can be bent.As the foreign matter was on the external surface of the catheter, the unit was sent in for ftir testing.Upon completing the ftir testing, results highlighted the presence of a silicone polymer of unknown formula.During manufacturing, a silicone material is used for tipping however the silicone is a clear lubricant and does not exhibit the solid and opaque properties as observed on the returned unit.As the device was unsealed, the defect of foreign matter cannot be conclusively attributed to the manufacturing process.As the foreign matter could have been picked up in the user environment.Operators perform gmp and gowning per the quality plan as well as periodic inspection for foreign matter per the sampling plan.Cleaning and bd 5s are perform my operators to maintain a clean work area and reduce potential introduction of foreign matter.Additionally, manufacturing is covered where possible to reduce and mitigate the introduction of environmental foreign.The complaint history review showed no other foreign matter complaints.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion(s): the defect of foreign matter was confirmed probable root cause conclusion(s): undetermined.

• Brand Name: BD INSYTE AUTOG BC
• 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: 18261883
• MDR Text Key: 330122003
• Report Number: 1710034-2023-01383
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903810239
• UDI-Public: (01)00382903810239
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Pharmacist
• 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: 381023
• Device Lot Number: 3045823
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2023
• Initial Date FDA Received: 12/04/2023
• Supplement Dates Manufacturer Received: 01/29/2024
• Supplement Dates FDA Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1