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

Catalog Number	381212
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the needle pierced through the bd insyte¿ iv catheter while introducing it.The following information was provided by the initial reporter: "insyte 24 kinking received testimony from the customer there are kinking during use insyte 24 insertion".
Additional Manufacturer Narrative
H6: investigation summary our quality engineer inspected the 2 photos submitted for evaluation.The reported issue of catheter kink / bent was not confirmed but needle through catheter was observed upon inspection of the photos.Analysis of one of the sample photos showed that catheter bent was not observed.Instead, it was observed that the needle pierced through the catheter near the adapter nose with the adapter being moved halfway from the needle hub.The blood in the catheter and needle flashback chamber indicated the product was used.The second photo showed the catheter adapter without the cannula and needle hub.The image was also too blurry to determine catheter bent defect.The root cause of the failure could not be determined since the sample in the photos is used.Needle pierced through catheter could happen when the product was manipulated during product insertion, but we cannot confirm how the product was used.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.H3 other text : see h10.
Event or Problem Description
It was reported that the needle pierced through the bd insyte¿ iv catheter while introducing it.The following information was provided by the initial reporter: "insyte 24 kinking received testimoni from the customer there are kinking during use insyte 24 insertion".

• 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 ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16299634
• Report Number: 8041187-2023-00045
• Device Sequence Number: 14973800
• Product Code: FOZ
• UDI-Device Identifier: 00382903812127
• UDI-Public: 00382903812127
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• 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,Followup
• Report Date (Section B): 03/02/2023

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 Catalogue Number: 381212
• Device Lot Number: 2207638
• 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: 01/13/2023
• Supplement Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 02/03/2023
• Supplement Report FDA Received Date: 03/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2022
• 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