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	Break (1069); Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1337251.Medical device expiration date: 30-nov-2024.Device manufacture date: 03-dec-2021.Medical device lot #: 9331601.Medical device expiration date: 31-dec-2022.Device manufacture date: 17-nov-2019.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 safety shield failed and broke off during use.The following information was provided by the initial reporter, translated from "today i received a complaint similar to the one below from my colleagues in anaesthesia.They have lot numbers 1337251 and 9331601.Photos of the complaint from anaesthesia.Speak for themselves.".
Additional Manufacturer Narrative
H6: investigation summary: three photos were received by our quality team for evaluation.From the first photo, the team observed that the catheter adapter was already activated from the needle hub.From the second and third photos, the team observed the spring, septum, and actuator detached out from the catheter adapter.A review of the internal manufacturing device records and raw material history files for the reported lot numbers were performed and no recorded quality problems or rejections to this incident were found.The team was unable to evaluate whether there is safety activation components failure / damage that resulted in the safety activation failure as no sample was returned.Therefore, the root cause could not be established.
Event or Problem Description
It was reported that the bd cathena¿ safety iv catheter with wings bd multiguard¿ technology safety shield failed and broke off during use.The following information was provided by the initial reporter, translated from "today i received a complaint similar to the one below from my colleagues in anaesthesia.They have lot numbers 1337251 and 9331601.Photos of the complaint from anaesthesia.Speak for themselves.".

• 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: 14547266
• Report Number: 8041187-2022-00269
• Device Sequence Number: 14745642
• Product Code: FOZ
• UDI-Device Identifier: 00382903868155
• UDI-Public: 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): 06/01/2022

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: Other
• Device Model Number: 386815
• Device Catalogue Number: 386815
• Device Lot Number: SEE SECTION H10
• 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: 05/02/2022
• Supplement Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 05/31/2022
• Supplement Report FDA Received Date: 07/01/2022
• 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