MAUDE Adverse Event Report: BECTON DICKINSON BD NEEDLE ECLIPSE 21X1-1/2 RB; INTRAVASCULAR CATHETER

Catalog Number	305765
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd needle eclipse 21x1-1/2 rb had foreign matter during the production process, a dirty cannula with black particles was discovered, please see the following pictures.This concerns your batch 4126045.To facilitate our internal evaluation, we kindly request information regarding your awareness of this defect and whether any similar analyses or potential causes have been investigated in the past.Please note that this is an enquiry and not an official complaint.Can you tell us the date of the incident? are samples available for examination? if so, where and from whom can we have it collected? address, telephone number and e-mail address are required.The date of the incident was (b)(6) 2025.Since this is only a single sample, we will be happy to send it to you.Could you give me the corresponding address? please send the sample to: bd gmbh martin ertl tullastr.8 -12 69126 heidelberg.Could you please check whether the sample we sent has arrived at your doorstep? the attached investigation report was prepared without the sample and does not contain any statements about the contamination.Yes, the pattern has arrived at me.The report is adjusted again and the pattern has been examined.
Additional Manufacturer Narrative
The complaint was found to be a duplicate of pr of (b)(4).Mdr submitted in (b)(4).
Event or Problem Description
No additional information.

• Brand Name: BD NEEDLE ECLIPSE 21X1-1/2 RB
• Common Device Name: 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: 21682399
• Report Number: 2243072-2025-00364
• Device Sequence Number: 8230613
• Product Code: FMI
• UDI-Device Identifier: 00382903057658
• UDI-Public: (01)00382903057658(11)240506(17)290430(10)4126045
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K010188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 305765
• Device Lot Number: 4126045
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown