MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. INSYTE AUTOGUARD PNK 20GA X 1.16IN; INTRAVASCULAR CATHETER

Model Number 381834

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

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

Event Date 03/01/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: our quality engineer inspected the photographs submitted for evaluation.Bd received two photos displaying four units.A visual inspection of the provided photos found that of the four photographed units and one had loose black foreign matter specks inside the packaging.All of the units were also observed to be sealed.As the device was sealed, the defect of foreign matter can be attributed to the manufacturing or packaging process.Preventative maintenance and visual inspections are performed during manufacturing, at regular intervals, to mitigate the risk from this type of defect.A device history record review showed no non-conformance's 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.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that insyte autoguard pnk 20ga x 1.16in had foreign matter.This occurred on 6 occasions.The following information was provided by the initial reporter: found during packaging, 6 catheters with particles inside.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-10-25.Investigation summary: our quality engineer inspected the samples and photographs submitted for evaluation.Bd received seven sealed 20ga x 1.16in insyte autoguard units from lot number 0300761.In addition, two photos were submitted.Upon inspection of the received units and the photos, it was observed that black specks are present inside four of the packages (units 1-4) and one unit had a black stain on the label (unit 5).The reported issue of foreign matter was confirmed.Regarding foreign matter on two of the units, this was physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect also relating to the packaging process.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.On one unit, the foreign matter is likely ink from the printing process.Two of the units, foreign matter was identified in the seal of the package therefore also confirming it to be from the packaging process.A device history record review showed no non-conformances associated with this issue during the production of these batches.H3 other text : see h10.

Event Description

It was reported that insyte autoguard pnk 20ga x 1.16in had foreign matter.This occurred on 6 occasions.The following information was provided by the initial reporter: found during packaging, 6 catheters with particles inside.

• Brand Name: INSYTE AUTOGUARD PNK 20GA X 1.16IN
• Type of Device: INTRAVASCULAR 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12563057
• MDR Text Key: 274744797
• Report Number: 1710034-2021-00855
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818341
• UDI-Public: 00382903818341
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/29/2024
• Device Model Number: 381834
• Device Catalogue Number: 381834
• Device Lot Number: 0300761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1