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

Catalog Number 381834

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/17/2023

Event Type  malfunction  

Manufacturer Narrative

D4.Medical device expiration date: unknown.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H4.Device manufacture date: unknown.

Event Description

It was reported that the bd insyte¿ iv catheter needle poked through the outer packaging of the bag before use.The following information was provided by the initial reporter: "unopened 20-gauge intravenous indwelling needle, missing the needle cover and the hard needle has been retracted, and the soft needle poked out of the outer packaging bag.".

Manufacturer Narrative

H.6.Investigation summary: a physical sample was not available for investigation but bd was provided with a photo of the issue for evaluation.A review of the device history record was performed for the reported lot, 2298017, and no quality issues were found during production.Our quality engineer reviewed the provided photo and observed that the needle cover was missing from the package.The device was also placed incorrectly inside of the packaging.The distal part of the unit was placed at the proximal side of the packaging.Additionally, the absence of the needle cover allowed the needle and catheter to pierce through the bottom portion of the packaging resulting in a sterility breach with part of the catheter sticking out.The engineer also noticed that the needle was already retracted inside of the barrel and that the package remained sealed.Therefore, based off the provided photo the engineer was able to verify the reported defects.It was determined that this was a manufacturing defect that occurred due to improper placement during packaging.The manufacturing facility has been notified of this incident and the findings.A notification has been issued to all packaging personnel to raise awareness of this issue and ensure that each device is being packaged correctly.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the bd insyte¿ iv catheter needle poked through the outer packaging of the bag before use.The following information was provided by the initial reporter: "unopened 20-gauge intravenous indwelling needle, missing the needle cover and the hard needle has been retracted, and the soft needle poked out of the outer packaging bag.".

Event Description

No additional information provided related to patient outcome.Unopened 20-gauge intravenous indwelling needle, missing the needle cover and the hard needle has been retracted, and the soft needle poked out of the outer packaging bag.

Manufacturer Narrative

(b)(6) 2023: post investigation contact with the customer reversed the initial confirmation of the affected material.Material updated to 381834 and lot number to 2298017.

• Brand Name: BD INSYTE¿ IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17477060
• MDR Text Key: 320710335
• Report Number: 8041187-2023-00407
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818341
• UDI-Public: (01)00382903818341
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/15/2023

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 Catalogue Number: 381834
• Device Lot Number: 2298017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2023
• Initial Date FDA Received: 08/07/2023
• Supplement Dates Manufacturer Received: 10/05/2023; 11/15/2023
• Supplement Dates FDA Received: 10/11/2023; 11/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2022
• 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