MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) INSYTE-N YEL 24GA X 0.56IN; INTERVASCULAR CATHETER

Model Number	381211
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2021
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 when using the insyte-n yel 24ga x 0.56in, the device experienced a needle through catheter while trying to introduce the catheter causing a hole in the catheter itself.This event occurred ten times.The following information was provided by the initial reporter.The customer stated: reports of ruptured cannula occurring in packaging.Additional reports of inserters loosening the needle off the plastic hub prior to insertion & the needle is rupturing through the side of the cannula.
Event or Problem Description
It was reported when using the insyte-n yel 24ga x 0.56in, the device experienced a needle through catheter while trying to introduce the catheter causing a hole in the catheter itself.This event occurred ten times.The following information was provided by the initial reporter.The customer stated: 1) reports of ruptured cannula occurring in packaging.2) additional reports of inserters loosening the needle off the plastic hub prior to insertion & the needle is rupturing through the side of the cannula.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2020-08-30.H6: investigation summary ten representative samples were received by our quality team for evaluation.The samples were subjected to visual inspection to check for the needle piercing through the catheter.On all ten samples, no needle pierced through the catheter was observed.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 assembly process was reviewed.If the needle pierced through catheter occurred in the manufacturing process, the defect would be detected and auto rejected by the inline tip spear vision inspection system.Needle pierced through catheter could also happened during product application when the product was manipulated.As no needle pierced through the catheter was detected on the returned samples, the root cause could not be established.The following controls have been put in place to prevent and detect the needle being pierced through catheter from occurring: the vision system camera is not out of focus when capturing the defect by using various metal blocks for different gauges to prevent the vision assembly from dropping under its weight and the catheter is aligned to one side using vacuum to aid the insertion of the cannula thus reducing the likelihood of this nonperformance from occurring.A daily challenge of the vision system is performed, and visual inspection is performed during outgoing inspection.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: INSYTE-N YEL 24GA X 0.56IN
• Common Device Name: INTERVASCULAR 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12450614
• Report Number: 8041187-2021-00821
• Device Sequence Number: 3578492
• Product Code: FOZ
• UDI-Device Identifier: 30382903812111
• UDI-Public: 30382903812111
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K151698
• 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): 10/14/2021

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: 02/28/2025
• Device Model Number: 381211
• Device Catalogue Number: 381211
• Device Lot Number: 0051148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2021
• Supplement Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2020
• 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