MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE¿ IV CATHETER 20 G X 1.16 IN.; INTRAVASCULAR CATHETER

Model Number	381234
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd insyte¿ iv catheter 20 g x 1.16 in.The catheter was damaged.There was no report of patient impact.The following information was provided by the initial reporter: this feedback from operating room of anesthesia department.Nurses complained that the needle is blunt when inserting iv catheter.When failing in inserting catheter, nurse withdrew catheter and saw that the catheter was broken at the tip.
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd insyte¿ iv catheter 20 g x 1.16 in.The catheter was damaged.There was no report of patient impact.The following information was provided by the initial reporter: this feedback from operating room of anesthesia department.Nurses complained that the needle is blunt when inserting iv catheter.When failing in inserting catheter, nurse withdrew catheter and saw that the catheter was broken at the tip.
Additional Manufacturer Narrative
Investigation summary: our quality engineer inspected the 2 photos submitted for evaluation.The reported issue of needle through catheter was confirmed upon inspection of the photos, but the reported defect of needle dull / blunt was not confirmed since the photos were too zoomed out to evaluate for that defect.Bd cannot confirm the cause of the failures to our manufacturing process since no sample was returned for evaluation.

• Brand Name: BD INSYTE¿ IV CATHETER 20 G X 1.16 IN.
• 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: 16915826
• Report Number: 8041187-2023-00209
• Device Sequence Number: 6555181
• Product Code: FOZ
• UDI-Device Identifier: 30382903812340
• UDI-Public: (01)30382903812340
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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): 05/17/2023

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 Model Number: 381234
• Device Catalogue Number: 381234
• Device Lot Number: 2225150
• 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: 04/20/2023
• Supplement Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2022
• 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