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

Model Number	381234
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	Vasculitis (2004)
Date of Event	06/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: based on device history record review, no abnormality was observed during the production of the affected batch.The routine catheter pull test and catheter leak test were within specifications.No quality notification was raised for the reported batch.Manufacturing review was performed at the icam assembly line and there is no misalignment which could cause damage to the catheter.Also, there is an automated vision inspection system at the icam line which can detect tip spear and reject the defective part if catheter tip damage occurred during the manufacturing process.The nonconformance could have happened out of the manufacturing facility during product application.As the actual sample was not returned for evaluation, actual root cause could not be established.
Event or Problem Description
It was reported that the bd insyte¿ iv catheter broke from its hub after removing the mandrel.The following information was provided by the initial reporter: the distal end of the catheter becomes detached when the mandrel is removed, leading to cases of venitis.
Additional Manufacturer Narrative
Correction: the following field was corrected: imdrf annex a grid: a0401 break.
Event or Problem Description
It was reported that the bd insyte¿ iv catheter broke from its hub after removing the mandrel.The following information was provided by the initial reporter: the distal end of the catheter becomes detached when the mandrel is removed, leading to cases of venitis.

• 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: 15080700
• Report Number: 8041187-2022-00384
• Device Sequence Number: 17152435
• Product Code: FOZ
• UDI-Device Identifier: 30382903812340
• UDI-Public: 30382903812340
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 08/22/2022

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: 07/31/2026
• Device Model Number: 381234
• Device Catalogue Number: 381234
• Device Lot Number: 1202119
• 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: 06/21/2022
• Supplement Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 07/21/2022
• Supplement Report FDA Received Date: 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2021
• 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