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

Model Number	386880
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd cathena¿ safety iv catheter the catheters were bending and in cases breaking in half.The following information was provided by the initial reporter: "just an fyi; the cancer center rn¿s are not at all happy with the new iv catheters.Stated that they bend and is some cases break in half.They are all complaining about them.Complaining is not unusual but usually by now they have adjusted to the new product.
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 while using bd cathena¿ safety iv catheter the catheters were bending and in cases breaking in half.The following information was provided by the initial reporter: "just an fyi; the cancer center rn¿s are not at all happy with the new iv catheters.Stated that they bend and is some cases break in half.They are all complaining about them.Complaining is not unusual but usually by now they have adjusted to the new product.
Additional Manufacturer Narrative
H6: investigation summary: one photo was received by our quality team for evaluation.The photo was visually inspected for a bent needle and broken needle.From the photo, the catheter was observed to be bent together with the needle at the base of the catheter adapter.The needle did not appear to be broken.A device history record review found no non-conformances associated with this issue during production of this batch.A simulated sample was tested in the lie distance 100% vision inspection system.The vision inspection system was able to fail and reject this sample due to the sample being out of the camera scope if the needle was bent.As no sample was returned for evaluation, an actual root cause could not be established.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD CATHENA¿ SAFETY 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: 15272380
• Report Number: 8041187-2022-00483
• Device Sequence Number: 5786744
• Product Code: FOZ
• UDI-Device Identifier: 00382903868803
• UDI-Public: 00382903868803
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K220584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2022

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: Health Professional
• Device Model Number: 386880
• Device Catalogue Number: 386880
• Device Lot Number: UNKNOWN
• 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: 08/04/2022
• Supplement Date Received by Manufacturer: 10/09/2022
• Initial Report FDA Received Date: 08/22/2022
• Supplement Report FDA Received Date: 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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