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

Catalog Number	381311
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/24/2019
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 catheter malfunction occurred at an unspecified time with a bd insyte-n¿iv catheter.The following information was provided by the initial reporter, "the user has been working with the product for a long time and loosens the needle on the venous indwelling cannula as recommended, just before it is used on the patient.Then, when repositioning the cannula, the piercing of the catheter material occurs.".
Additional Manufacturer Narrative
Investigation summary: bd received seven 24 gauge insyte-n winged units from lot 8326824 for evaluation.A review of the device history record was performed for the reported lot and no quality issues were found during production.Our quality engineer visually inspected the returned units and observed catheter damage to one unit and the other six showed signs of the needle piercing through the catheter tubing.Based off the visual inspection the engineer was able to verify the reported defect.Unfortunately, a definitive root cause could not be identified for this issue.The manufacturing facility has been notified of this incident and the findings.
Event or Problem Description
It was reported that catheter malfunction occurred at an unspecified time with a bd insyte-n¿iv catheter.The following information was provided by the initial reporter, "the user has been working with the product for a long time and loosens the needle on the venous indwelling cannula as recommended, just before it is used on the patient.Then, when repositioning the cannula, the piercing of the catheter material occurs.".

• Brand Name: BD INSYTE-N¿IV CATHETER
• Common Device Name: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8852601
• Report Number: 8041187-2019-00596
• Device Sequence Number: 2000430
• Product Code: FOZ
• UDI-Device Identifier: 30382903813118
• UDI-Public: 30382903813118
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 381311
• Device Lot Number: 8326824
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 08/01/2019
• Supplement Report FDA Received Date: 10/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other