MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE-N¿ PERIPHERAL VENOUS CATHETER; INTRAVASCULAR CATHETER

Catalog Number	381311
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2022
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 while using bd insyte-n¿ peripheral venous catheter the tip of the catheter was found to be defective.There was no report of patient impact.The following information was provided by the initial reporter: at the time of inserting the nurse took the dm out of its packaging.At the time of pricking, impossible to pierce the skin of the child.Looking more closely, she realizes that the catheter is defective at its distal end (entry point).
Event or Problem Description
It was reported while using bd insyte-n¿ peripheral venous catheter the tip of the catheter was found to be defective.There was no report of patient impact.The following information was provided by the initial reporter: at the time of inserting the nurse took the dm out of its packaging.At the time of pricking, impossible to pierce the skin of the child.Looking more closely, she realizes that the catheter is defective at its distal end (entry point).
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 13-apr-2022.H.6.Investigation: one sample with open packaging was received by our quality team for evaluation.The sample was subjected to visual inspection.A ¿v-cut¿ was observed near the catheter tip.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.From the returned sample, a ¿v-cut¿ was observed on the catheter that matches the bevel shape, which could be caused by the needle piercing through the catheter.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 happen during product application when the product was manipulated.As the sample was returned in open packaging, the actual root cause could not be established.

• Brand Name: BD INSYTE-N¿ PERIPHERAL VENOUS 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: 13802356
• Report Number: 8041187-2022-00129
• Device Sequence Number: 14700830
• Product Code: FOZ
• UDI-Device Identifier: 00382903813117
• UDI-Public: 00382903813117
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: NA
• 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): 05/11/2022

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: 12/31/2025
• Device Catalogue Number: 381311
• Device Lot Number: 0325845
• 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: 03/03/2022
• Supplement Date Received by Manufacturer: 05/11/2022
• Initial Report FDA Received Date: 03/17/2022
• Supplement Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2020
• 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