MAUDE Adverse Event Report: BD MEDICAL, MEDICATION DELIVERY SOLUTIONS BD EMERALD SYRINGE; INTRAVASCULAR CATHETER

Catalog Number 307754

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

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

Event Date 01/31/2024

Event Type  malfunction  

Event Description

It was reported that bd emerald syringe had foreign matter the following information was received by the initial reporter with the following verbatim: there is some dust particles inside the syringe.

Manufacturer Narrative

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

Manufacturer Narrative

02 samples & 01 photograph were received by bd for evaluation.A quality engineer was able to review the photographs of lot #3146975 regarding item #(b)(4) with the reported issue that ¿foreign matter¿.Based on received photographs & samples foreign matter is visible in the syringe pack.The investigation and simulation were carried out on retention samples where the investigating team has visually inspected the samples for ¿foreign matter "and no such type of defect was found in retention samples.

Event Description

There is some dust particals inside the syringe.

• Brand Name: BD EMERALD SYRINGE
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD MEDICAL, MEDICATION DELIVERY SOLUTIONS; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL, MEDICATION DELIVERY SOLUTIONS; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18797672
• MDR Text Key: 337186523
• Report Number: 2243072-2024-00221
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: NA
• 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
• Report Date: 04/11/2024

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: 307754
• Device Lot Number: 3146975
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2024
• Initial Date FDA Received: 02/28/2024
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1