MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD CATHENA¿ SAFETY IV CATHETER; 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	08/17/2022
Type of Reportable Event	Malfunction
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 needle pierced through the bd cathena¿ safety iv catheter while introducing it.The following information was provided by the initial reporter: "the iv was started in the preoperative area, the stylette and catheter separated inappropriately.Anecdotally, the anesthesia assistant that witnessed the event reported that she has seen this before - yet it was unreported.".
Event or Problem Description
It was reported that the needle pierced through the bd cathena¿ safety iv catheter while introducing it.The following information was provided by the initial reporter: "the iv was started in the preoperative area, the stylette and catheter separated inappropriately.Anecdotally, the anesthesia assistant that witnessed the event reported that she has seen this before - yet it was unreported.".
Additional Manufacturer Narrative
H6: investigation summary: three photos and one used actual sample with open packaging were received by our quality team for evaluation.From the photos, the needle was observed to be pierced through the catheter at the nose of the catheter adapter.The sample was subjected to visual inspection.The needle was observed to be pierced through the catheter at the nose of the catheter adapter.A blood stain was observed in the catheter tubing, so the sample was used.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.The manufacturing process was reviewed and investigated.No station was found which could potentially lead to the reported defect.As the returned sample was used, the needle piercing through the catheter most likely occurred during product application when the product was manipulated.

• 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: 15407236
• Report Number: 8041187-2022-00532
• Device Sequence Number: 14858022
• Product Code: FOZ
• UDI-Device Identifier: 00382903868636
• UDI-Public: 00382903868636
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K201717
• 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): 10/11/2022

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: 10/31/2024
• Device Model Number: 386863
• Device Catalogue Number: 386863
• Device Lot Number: 1294876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2022
• Supplement Date Received by Manufacturer: 10/11/2022
• Initial Report FDA Received Date: 09/12/2022
• Supplement Report FDA Received Date: 10/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2021
• 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