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

Catalog Number	381211
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that insyte-n yel 24ga x 0.56in catheter tip was damaged.The following information was provided by the initial reporter: neonatal catheter # 24 when removing it from the packaging is observed the ruptured catheter tip, quality question.
Additional Manufacturer Narrative
H.6.Investigation: five photos were received by our quality team for evaluation.From the photos, a notch was observed near the cannula tip.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.The insyte-n product is designed with a notch on the cannula tip as a product feature for flashback visual indication.Therefore, this is not a product defect.
Event or Problem Description
It was reported that insyte-n yel 24ga x 0.56in catheter tip was damaged.The following information was provided by the initial reporter: neonatal catheter # 24 when removing it from the packaging is observed the ruptured catheter tip, quality question.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-09-14.Investigation summary: five photos were received by our quality team for evaluation.From the photos, a notch was observed near the cannula tip.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.The insyte-n product is designed with a notch on the cannula tip as a product feature for flashback visual indication.Therefore, this is not a product defect.One sample was later received with open packaging by our quality team for evaluation.The sample was subjected to visual inspection to check for catheter and cannula tip defect.A notch was observed near the cannula tip.A ¿v-cut¿ was also observed near the cannula tip.This cut matches the shape of the bevel and could be caused by the needle piercing through the catheter.The assembly process was reviewed.If the needle pierced through the catheter during the manufacturing process, the defect would be detected and auto rejected by the inline tip spear vision system inspection system.This can also occur when the product was manipulated.As the sample was returned in open packaging and used from the evidence of the blood stain in the cannula tip notch, the actual 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.H3 other text : see h10.
Event or Problem Description
It was reported that insyte-n yel 24ga x 0.56in catheter tip was damaged.The following information was provided by the initial reporter: neonatal catheter # 24 when removing it from the packaging is observed the ruptured catheter tip, quality question.

• Brand Name: INSYTE-N YEL 24GA X 0.56IN
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11935842
• Report Number: 8041187-2021-00462
• Device Sequence Number: 3249521
• Product Code: FOZ
• UDI-Device Identifier: 00382903812110
• UDI-Public: 00382903812110
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Followup
• Report Date (Section B): 10/28/2021

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: 11/30/2024
• Device Catalogue Number: 381211
• Device Lot Number: 9326123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 05/07/2021
• Supplement Date Received by Manufacturer: 07/15/2021; 10/28/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 08/05/2021; 11/17/2021
• 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