MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE-W¿ PERIPHERAL VENOUS CATHETER; INTRAVASCULAR CATHETER

Model Number	381323
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd insyte-w¿ peripheral venous catheter the experienced needle through catheter.There was no report of patient impact.The following information was provided by the initial reporter, translated from dutch to english: recently found multiple needles on l1 and m2 where iv needle is defective.Plastic catheter is on hook.Basically, this a problem that does happen more often when you've just made the wrong angle and are against the vessel wall but could of course be that in these cases plastic was also affected beforehand.Have only seen it with blue needles.
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
Our quality engineer inspected the 1 photo submitted for evaluation.The reported issues of catheter tip integrity and catheter kink/bent was confirmed upon inspection of the photo.However, bd cannot confirm the causes of the failures to our manufacturing process since no sample was returned for evaluation.We would be very interested in examining product that does not meet your expectations and our quality standards.Examination of the actual product involved may provide clarification as to the cause of the reported failure.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.We regret any inconveniences this incident may have caused you and your facility.
Event or Problem Description
No additional information.

• Brand Name: BD INSYTE-W¿ PERIPHERAL VENOUS 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: 16044487
• Report Number: 8041187-2022-00769
• Device Sequence Number: 20399894
• Product Code: FOZ
• UDI-Device Identifier: 30382903813231
• UDI-Public: (01)30382903813231
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 07/12/2024

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 Model Number: 381323
• Device Catalogue Number: 381323
• Device Lot Number: 2054679
• 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: 11/23/2022
• Supplement Date Received by Manufacturer: 12/29/2022
• Initial Report FDA Received Date: 12/23/2022
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2022
• 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