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

Catalog Number 302032

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

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

Event Date 02/21/2024

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 18g 1-1/2in tw had foreign matter the following information was provided by the initial reporter: complaint from (b)(6)hospital.The customer complained that foreign body was found inside the product.

Event Description

Complaint from (b)(6) hospital.The customer complained that foreign body was found inside the product.

Manufacturer Narrative

Based on the ftir results, there was no good match in the spectrum library for the brown foreign matter.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 of fm on shield at the assembly in-process inspection.Actual root cause could not be determined.The complaint trend will continued to be tracked and monitored.

• Brand Name: BD NEEDLE 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
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18926822
• MDR Text Key: 337945357
• Report Number: 2243072-2024-00296
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903020325
• UDI-Public: (01)30382903020325
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/22/2024

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: 302032
• Device Lot Number: 3142788
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2024
• Initial Date FDA Received: 03/18/2024
• Supplement Dates Manufacturer Received: 04/22/2024
• Supplement Dates FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1