MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE¿ PERIPHERAL IV CANNULA WITH BD VIALON¿ BIOMATERIAL; INTRAVASCULAR CATHETER

Catalog Number	381223
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the needle pierced through the bd insyte¿ peripheral iv cannula with bd vialon¿ biomaterial while attempting to insert the iv.The following information was provided by the initial reporter: on friday afternoon, (b)(6) 2023, one of our doctors attempted to use the cannula to insert an iv line into a patient¿s l) cubital fossa.As he tried to push the trochar through the skin the tip of the cannula lifted preventing the cannula from entering the vein though the trochar tip had penetrated it.No damage was done to the patient as it was noticed and withdrawn immediately.Subsequent cannulation with a cannula from the same batch caused no issues.The cannula had been stored at room temperature as do all our others and was opened just prior to use.It was not placed on any surface after the cap had been removed so we could not have accidentally damaged it.This is the first time that either the doctor or myself had come across this issue.
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary our quality engineer inspected the 1 photo submitted for evaluation.The reported issue of needle through catheter was confirmed upon inspection of the photo.It was observed that the needle pierced through the catheter near the tip, and there was also a blood stain at the needle hub.There are currently processes in place to help catch and prevent this failure mode during the manufacturing process.There is a possibility the defect observed occurred during the application of the device, but since the samples is shown to be used that root cause cannot be confirmed.
Event or Problem Description
It was reported that the needle pierced through the bd insyte¿ peripheral iv cannula with bd vialon¿ biomaterial while attempting to insert the iv.The following information was provided by the initial reporter: "on friday afternoon, (b)(6) 2023, one of our doctors attempted to use the.Cannula to insert an iv line into a patient¿s l) cubital fossa.As he tried to push the trochar through the skin the tip of the cannula lifted.Preventing the cannula from entering the vein though the trochar tip had penetrated it.No damage was done to the patient as it was noticed and withdrawn immediately.Subsequent cannulation with a cannula from the same batch caused no issues.The cannula had been stored at room temperature as do all our others and was opened just prior to use.It was not placed on any surface after the cap had been removed so we could not have accidentally damaged it.This is the first time that either the doctor or myself had come across this issue".

• Brand Name: BD INSYTE¿ PERIPHERAL IV CANNULA WITH BD VIALON¿ BIOMATERIAL
• 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 ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17076560
• Report Number: 8041187-2023-00258
• Device Sequence Number: 6346238
• Product Code: FOZ
• UDI-Device Identifier: 00382903812233
• UDI-Public: 00382903812233
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2023

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: Health Professional
• Device Expiration Date: 08/31/2026
• Device Catalogue Number: 381223
• Device Lot Number: 1230104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2023
• Supplement Date Received by Manufacturer: 06/12/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2021
• 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