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

Model Number	386863
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.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 during insertion with bd cathena- safety iv catheter, bd multiguard technology it was difficult to advance and was discovered that the needle had punctured the catheter.There was no patient impact.The following information was provided by the initial reporter: ¿while inserting a #20 peripheral iv, rn had difficulty advancing the catheter over the needle.When she removed, it appears that the needle punctured the catheter.Product is bd cathena- safety iv catheter, bd multiguard technology.Lot number is 2215681.
Event or Problem Description
It was reported that during insertion with bd cathena- safety iv catheter, bd multiguard technology it was difficult to advance and was discovered that the needle had punctured the catheter.There was no patient impact.The following information was provided by the initial reporter: ¿while inserting a #20 peripheral iv, rn had difficulty advancing the catheter over the needle.When she removed, it appears that the needle punctured the catheter.Product is bd cathena- safety iv catheter, bd multiguard technology.Lot number is 2215681.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 25-jul-2023.H6: investigation summary: our quality engineer inspected the 1 used sample submitted for evaluation.The reported issue of needle through catheter was confirmed upon inspection of the sample.Analysis of the sample showed that the needle pierced through the mid-section of the catheter, and there were blood stains in the catheter tubing.Bd determined that a possible cause of the failure could be related to the handling of the product during use.However, since the product was returned used, we cannot confirm how the product was exactly used, so this root cause cannot be confirmed.Our manufacturing process was reviewed and there are currently controls in place to detect and reject the defect observed.Production records were reviewed, and this batch meets our manufacturing specification requirements.H3 other text : see h10.

• Brand Name: BD CATHENA- SAFETY IV CATHETER, 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 ; 8448235433
• MDR Report Key: 17295237
• Report Number: 8041187-2023-00329
• Device Sequence Number: 3994706
• Product Code: FOZ
• UDI-Device Identifier: 00382903868636
• UDI-Public: (01)00382903868636
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2023

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 Expiration Date: 07/31/2025
• Device Model Number: 386863
• Device Catalogue Number: 386863
• Device Lot Number: 2215681
• 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: 06/15/2023
• Supplement Date Received by Manufacturer: 08/02/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2022
• 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