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

Model Number	386815
Medical Device Problem Codes	Retraction Problem (1536); Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd cathena¿ safety iv catheter with wings bd multiguard¿ technology the spring remained in the cannula after removing the safety needle.The following information was provided by the initial reporter, translated from dutch."a few weeks ago i spoke to you about a complaint with the yellow neoflons from bd.The spring remained in the cannula after removing the safety needle.We thought that it was limited to one particular lot number at the time, but now today we have found neoflons again with the same problem, and a different lot number.I have opened a number of them and they all had the problem.Some other lot numbers did not.I have taken them out of service again.This time it was a large part of our stock!" also this time it concerns the alternative the cathena with ref 386815 but now with lot number: 1337251.
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 the bd cathena¿ safety iv catheter with wings bd multiguard¿ technology the spring remained in the cannula after removing the safety needle.The following information was provided by the initial reporter, translated from dutch."a few weeks ago i spoke to you about a complaint with the yellow neoflons from bd.The spring remained in the cannula after removing the safety needle.We thought that it was limited to one particular lot number at the time, but now today we have found neoflons again with the same problem, and a different lot number.I have opened a number of them and they all had the problem.Some other lot numbers did not.I have taken them out of service again.This time it was a large part of our stock!" also this time it concerns the alternative the cathena with ref (b)(4) but now with lot number: 1337251.
Additional Manufacturer Narrative
The following information was corrected: h.6.Imdrf annex a code: a0510.Investigation summary: 61 samples were received by our quality team for evaluation.36 samples, two actual samples in open packaging and 34 representative samples in sealed packaging, were received from the reported batch 1337251 and 25 representative samples in sealed packaging were received from the unreported batch 9331601.The two actual samples were received were subjected to visual inspection to check for safety activation failure.Only the catheter adapter was returned, and the spring was found to be intact in the catheter adapter.The representative samples from both batches passed the safety activation test.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the evaluation on the returned actual samples of the reported batch, the spring, which is one of the blood control components, was found intact in the catheter adapter.This is inconsistent with the verbatim, ¿the spring remained in the cannula after removing the safety needle.¿ as all representative samples passed the safety activation testing with no safety activation failure detected, a root cause cannot 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 WITH WINGS BD MULTIGUARD¿ TECHNOLOGY
• 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: 14598338
• Report Number: 8041187-2022-00285
• Device Sequence Number: 12215104
• Product Code: FOZ
• UDI-Device Identifier: 00382903868155
• UDI-Public: (01)00382903868155
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K172506
• 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): 10/17/2022

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 Expiration Date: 11/30/2024
• Device Model Number: 386815
• Device Catalogue Number: 386815
• Device Lot Number: 1337251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2022
• Supplement Date Received by Manufacturer: 10/18/2022
• Initial Report FDA Received Date: 06/03/2022
• Supplement Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2021
• 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