MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE¿ IV CATHETER; INTRAVASCULAR CATHETER

Model Number	381212
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: our quality engineer inspected the 2 samples without unit packaging submitted for evaluation.The reported issue of catheter tip integrity was confirmed but the defects of catheter releases prematurely and stylet damaged / defective were not confirmed upon inspection of the samples.However, the defect of needle through catheter was observed during our examination.Analysis of the sample showed that both samples had damages to the catheter, with one having a v cut near the tip of the catheter and the other had the needle pierced through the catheter near the tip area.Bd cannot confirm the causes of the needle through catheter and catheter tip integrity defects were a result of the manufacturing process since the products were returned in a used state.Since both were used there is a possibility that the catheter damages could have been caused during use.There were no damages to the adapter and needle hub present, there for the defect of catheter releases prematurely was not confirmed.A root cause could not be determined since the defect was not confirmed by the sample evaluation.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.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 or Problem Description
It was reported that the bd insyte¿ iv catheter experienced needle through catheter while introducing catheter.The following information was provided by the initial reporter: problem observed: very difficult to prick the baby's skin.On one of the catheters, on removal, we notice that the plastic mandrel is all damaged.We have the impression that we are pricking with the plastic guide and not the needle: pain, failure to insert the peripheral venous line.On the other hand, the catheter is easily detached from the mandrel and one is obliged to maintain the whole to prick the baby, knowing that the approaches are often complicated to find and that it is necessary to be several to hold the baby.Immediate action: change of the device.Patient impact: pain when injecting, failure to insert peripheral venous line professional impact: failure to insert peripheral venous line, attempt by another colleague.

• Brand Name: BD INSYTE¿ IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16963099
• Report Number: 8041187-2023-00221
• Device Sequence Number: 20181445
• Product Code: FOZ
• UDI-Device Identifier: 30382903812128
• UDI-Public: (01)30382903812128
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/25/2023

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: 05/31/2025
• Device Model Number: 381212
• Device Catalogue Number: 381212
• Device Lot Number: 0141902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown