MAUDE Adverse Event Report: BECTON DICKINSON BD INSYTE GN 18GA X 1.16IN; INTRAVASCULAR CATHETER

Catalog Number	381244
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd insyte gn 18ga x 1.16in catheter tip integrity at the moment of using the catheter, the tip of the catheter loses its shape and bifurcates.In one of the two procedures performed, the use of this part caused damage to a vein in the patient (rupture of the vein wall).We therefore require your support to process this complaint as a suspected adverse incident, which procomsa classifies as level 1 - minor incident.
Additional Manufacturer Narrative
Our quality engineer inspected the photos submitted for evaluation.The reported issue of catheter tip integrity was not confirmed upon inspection of the photos.Bd cannot confirm the cause of the failure to our manufacturing process since no physical sample was returned.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.
Event or Problem Description
At the moment of using the catheter, the tip of the catheter loses its shape and bifurcates.In one of the two procedures performed, the use of this part caused damage to a vein in the patient (rupture of the vein wall).We therefore require your support to process this complaint as a suspected adverse incident, which procomsa classifies as level 1 - minor incident.
Event or Problem Description
At the moment of using the catheter, the tip of the catheter loses its shape and bifurcates.In one of the two procedures performed, the use of this part caused damage to a vein in the patient (rupture of the vein wall).We therefore require your support to process this complaint as a suspected adverse incident, which classifies as level 1 - minor incident.
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of the affected batch.The tipping sub-assembly machine was reviewed.The catheter is pre-cut to required length, form of the required catheter tip and then load to the catheter tipper pallet.Based on the evaluation of sample 1 and 3, the damage on the catheter tip is slanted in position.The catheter pre-cut process cuts the catheter in horizontal position and the catheter tipping process forms the catheter tip which is different from the catheter tip damage position.Therefore, the tipping process is unlikely the cause for the catheter tip damage.The assembly process was reviewed, and the only station that is in contact with the catheter tubing is the rubber pads at the flaring station.Given the elastic nature of the rubber pads and there are no sharp or hard edges on the pads, this station is unlikely to cause damages on the catheter.Current control, there is an in-process visual inspection in place to check for catheter damage.There is also functional test in place to check for catheter tip penetration force.As the samples had been used and based on the damage position on the catheter tip for sample 1 and 3, it is suspected that the damage could be inflicted during application.The complaint trend will continue to be tracked and monitored.

• Brand Name: BD INSYTE GN 18GA X 1.16IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20322765
• Report Number: 2243072-2024-01000
• Device Sequence Number: 8005433
• Product Code: FOZ
• UDI-Device Identifier: 00382903812448
• UDI-Public: (01)00382903812448(11)230908(17)280831(10)3251845
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/04/2024

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: Health Professional
• Device Catalogue Number: 381244
• Device Lot Number: 3251845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 10/16/2024; 11/04/2024
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 10/16/2024; 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown