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

Catalog Number	381334
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the needle pierced through the bd insyte-w¿ peripheral venous catheter while introducing it into the patient.The following information was provided by the initial reporter, translated from french: "i would like to inform you of a defect reported by a nurse from one of our elivie patients.2 catheters concerned.1 catheter insyte ail.20g/30mm lot 2176969.1 catheter insyte ail.22g/30mm lot 2209621.When inserting the mandrel, the catheter does not follow.Presence of a catheter protrusion that does not allow insertion.No consequences for the patient.The idel put back a catheter with a model that she had in her stock.
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.6.Investigation summary: our quality engineer inspected the 5 photos submitted for evaluation.The reported issue of peelback was not confirmed but a failure of needle through catheter was confirmed upon inspection of the photos.However, bd cannot confirm the cause of the failure to our manufacturing process since no sample was returned for evaluation.Examination of the actual product involved may provide clarification as to the cause of the reported failure.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.

• 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 ; 8448235433
• MDR Report Key: 16829891
• Report Number: 8041187-2023-00181
• Device Sequence Number: 1942985
• Product Code: FOZ
• UDI-Device Identifier: 00382903813346
• UDI-Public: 00382903813346
• 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
• Report Date (Section B): 04/06/2023

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: Health Professional
• Device Catalogue Number: 381334
• Device Lot Number: 2176969
• 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: 04/05/2023
• Initial Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2022
• 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