MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE¿, PERIPHERAL IV CANNULA, BD VIALON¿ BIO MATERIAL; INTRAVASCUALR CATHETER

Catalog Number	381223
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd insyte¿, peripheral iv cannula, bd vialon¿ bio material the catheter was damaged.There was no report of patient impact.The following information was provided by the initial reporter: before using the indentation needle, open the package, check the needle core, find a white ring on the upper end of the hose, suspected to produce creases, replace the product.
Additional Manufacturer Narrative
Our quality engineer inspected the 1 photo submitted for evaluation.The reported issue of catheter defective / damaged was not confirmed upon inspection of the photo.The photo provided was too blurry and zoomed out to evaluate the sample for the defect.Bd cannot confirm the cause of the failure to our manufacturing process since no sample was returned for evaluation.Device history record of packaged needle (pn) batch 2330040 catalogue number 381223 and its assembled needle (an) batch 2330096, part number yf01223sgt was reviewed.H3 other text : see h10.
Event or Problem Description
It was reported while using bd insyte¿, peripheral iv cannula, bd vialon¿ bio material the catheter was damaged.There was no report of patient impact.The following information was provided by the initial reporter: before using the indentation needle, open the package, check the needle core, find a white ring on the upper end of the hose, suspected to produce creases, replace the product.

• Brand Name: BD INSYTE¿, PERIPHERAL IV CANNULA, BD VIALON¿ BIO MATERIAL
• Common Device Name: INTRAVASCUALR 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17770239
• Report Number: 8041187-2023-00494
• Device Sequence Number: 7073316
• Product Code: FOZ
• UDI-Device Identifier: 30382903812234
• UDI-Public: (01)30382903812234
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2023

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: 381223
• Device Lot Number: 2330040
• 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: 08/31/2023
• Supplement Date Received by Manufacturer: 10/09/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2022
• 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