MAUDE Adverse Event Report: BECTON DICKINSON BD NEEDLE BLUNT 18G 1-1/2IN TW; INTRAVASCULAR CATHETER

Catalog Number 300204

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 11/20/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that bd needle blunt 18g 1-1/2in tw had foreign matter the following information was provided by the initial reporter: we had a drawing up needle which had rust or bloodstained liquid insitu when nurses opened the packaging this morning.It was completely sealed prior to use and when staff connected it to the syringe it discoloured the solution within the syringe to yellow.The device involved in the case was not used on a patient.Items from the same box are quarantined.Email notifications have been sent to sa health procurement team and the central adelaide local health network safety and quality unit.

Manufacturer Narrative

Based on device history record review, no abnormality was observed during the production of the affected batches.Current control there is a visual inspection on foreign matter at the qa outgoing inspection and visual inspection on foreign matter at the assembly in-process inspection.Actual root cause could not be determined as no photo/sample received for investigation.The complaint will be re-opened and re-investigated when sample is received.

Event Description

We had a drawing up needle which had rust or bloodstained liquid insitu when nurses opened the packaging this morning.It was completely sealed prior to use and when staff connected it to the syringe it discoloured the solution within the syringe to yellow.The device involved in the case was not used on a patient.Items from the same box are quarantined.Email notifications have been sent to sa health procurement team and the central adelaide local health network safety and quality unit.

• Brand Name: BD NEEDLE BLUNT 18G 1-1/2IN TW
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18379892
• MDR Text Key: 331204519
• Report Number: 2243072-2023-02232
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903002047
• UDI-Public: (01)00382903002047
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/05/2024

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: 300204
• Device Lot Number: 3201327
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 03/05/2024
• Supplement Dates FDA Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2023
• 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