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

Model Number 381211

Device Problem Material Puncture/Hole (1504)

Patient Problem Insufficient Information (4580)

Event Date 09/24/2021

Event Type  malfunction  

Event Description

It was reported that bd insyte-n¿ iv catheter had a needle through the catheter while introducing the catheter.The following information was provided by the initial reporter: "the stylet of several bd insyte venous catheters 0.7x14mm were drilled during laying by the guide resulting in installation failure.".

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd insyte-n¿ iv catheter had a needle through the catheter while introducing the catheter.The following information was provided by the initial reporter: "the stylet of several bd insyte venous catheters 0.7x14mm were drilled during laying by the guide resulting in installation failure.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval? yes.D10: returned to manufacturer on: 2022-feb-15.H6: investigation summary: one sample was received by our quality team for evaluation.The returned product does not belong to the tuas plant insyte manufacturing process.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.

• Brand Name: BD INSYTE-N¿ IV CATHETER
• Type of Device: 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: 13499170
• MDR Text Key: 286344090
• Report Number: 8041187-2022-00076
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903812111
• UDI-Public: 30382903812111
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K151698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/10/2022

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
• Device Operator: Other
• Device Model Number: 381211
• Device Catalogue Number: 381211
• Device Lot Number: 0296601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2022
• Initial Date FDA Received: 02/09/2022
• Supplement Dates Manufacturer Received: 03/10/2022
• Supplement Dates FDA Received: 03/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1