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

Catalog Number	386802
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d.4.Medical device lot #: 2174730.D.4.Medical device expiration date: 30-jun-2025.H.4.Device manufacture date: 23-jun-2022.D4.Medical device lot #: unknown.D4.Medical device expiration date: unknown.H4.Device manufacture date: unknown.H3.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 separated after a period of time.The following information was provided by the initial reporter, translated from spanish to english: catheter separation: "devices connected to the catheter are disconnected after a period of time.".
Additional Manufacturer Narrative
Correction: imdrf annex b grid: b03, b05, b14.
Event or Problem Description
It was reported that the bd cathena¿ safety iv catheter separated after a period of time.The following information was provided by the initial reporter, translated from spanish to english: catheter separation: "devices connected to the catheter are disconnected after a period of time.".
Additional Manufacturer Narrative
The following fields have been updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 10-aug-2023.H.6.Investigation summary: our quality engineer inspected the 1 unused sample submitted for evaluation.The reported issues of phlebitis, catheter defective / damaged, leakage at insertion site, separation catheter from adapter were not confirmed upon inspection and testing of the samples.Analysis of the sample showed that there was no foreign matter present and no damages.The sample also underwent leakage testing, and no leakage was observed.Bd could not determine a manufacturing related root cause since the reported defect was not confirmed during the evaluation of the sample.Production records were reviewed, and this batch meets our manufacturing specification requirements.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.
Event or Problem Description
It was reported that the bd cathena¿ safety iv catheter separated after a period of time.The following information was provided by the initial reporter, translated from spanish to english: catheter separation: "devices connected to the catheter are disconnected after a period of time.".

• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17466797
• Report Number: 8041187-2023-00392
• Device Sequence Number: 7134761
• Product Code: FOZ
• UDI-Device Identifier: 00382903868025
• UDI-Public: (01)00382903868025
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/12/2023

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: Other
• Device Catalogue Number: 386802
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2023
• Supplement Date Received by Manufacturer: 09/25/2023; 10/09/2023
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 10/04/2023; 10/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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