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

Model Number	381311
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2022
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 insyte-n¿ iv catheter while introducing it.The following information was provided by the initial reported: "she stitches in when she repositions it.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 18-apr-2022.H6: investigation summary: sixteen (16) samples, one actual unused sample in open packaging and fifteen (15) representative samples in sealed packaging, were received by our quality team for evaluation.The actual sample was subjected to visual inspection to check for bent catheter.No bent catheter was observed.The representative samples were subjected to visual inspection to check for catheter damage.All samples passed the visual inspection with no catheter damage 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.Based on the quality team's investigation, the root cause of this incident cannot be determined.
Event or Problem Description
It was reported that the needle pierced through the bd insyte-n¿ iv catheter while introducing it.The following information was provided by the initial reported: "she stitches in when she repositions it.".

• Brand Name: BD INSYTE-N¿ 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: 14147433
• Report Number: 8041187-2022-00202
• Device Sequence Number: 2846145
• Product Code: FOZ
• UDI-Device Identifier: 30382903813118
• UDI-Public: 30382903813118
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 05/20/2022

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: 07/31/2026
• Device Model Number: 381311
• Device Catalogue Number: 381311
• Device Lot Number: 1203948
• 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: 03/28/2022
• Supplement Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2021
• 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