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

Model Number	381212
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2023
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 bd insyte¿ iv catheter the canula over needle was deformed.Canula over needle was deformed ¿ the canula was pierced by the needle and deformed (the canula was bent while the needle was straight; as a result of which the canula was pierced by the needle).Visual inspection of the catheter/needle assembly revealed the needle cannula protruding through the catheter body near the distal tip.No damage was noted to the returned arterial catheter.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 17-feb-23 h6: investigation summary our quality engineer inspected the 2 photos and 1 sample submitted for evaluation.The reported issue of needle through catheter was confirmed upon inspection and testing of the sample.Analysis of the sample showed that the needle pierced through catheter near the tip area.Bd could not determine a manufacturing related root cause of the defect.The sample was run through our auto reject systems and each properly rejected the returned sample.These results supports that the root cause did not occur in our manufacturing process.There is the possibility the defect occurred during the application of the product, but we cannot confirm this root cause since we cannot confirm how the sample was used.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 bd insyte¿ iv catheter the canula over needle was deformed canula over needle was deformed ¿ the canula was pierced by the needle and deformed (the canula was bent while the needle was straight; as a result of which the canula was pierced by the needle).Visual inspection of the catheter/needle assembly revealed the needle cannula protruding through the catheter body near the distal tip.No damage was noted to the returned arterial catheter.

• 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 ; 8448235433
• MDR Report Key: 16459159
• Report Number: 8041187-2023-00066
• Device Sequence Number: 14076872
• Product Code: FOZ
• UDI-Device Identifier: 30382903812128
• UDI-Public: (01)30382903812128
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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): 03/06/2023

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: 04/30/2026
• Device Model Number: 381212
• Device Catalogue Number: 381212
• Device Lot Number: 1110943
• 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: 02/02/2023
• Supplement Date Received by Manufacturer: 03/06/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 03/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2021
• 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