MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 18X1IN BLUNT FILL; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Catalog Number	305181
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Good morning, we have received in the area of surveillance of medical devices of the spanish agency of medicines and medical devices, notification from the health professional (b)(6) (with email (b)(6)), regarding an incident with the medical device bd blunt fill needle, model 18g x 1 tw (1.2mm x 25 mm), serial number unknown, lot number 3086629, occurred on (b)(6) 2024, in the c.S severo ochoa, gijón, asturias.The information provided is as follows: description of the incident: the medication loading needle described is not safe for medication preparation as although it minimises the risk of puncture, the blunt tip requires exerting more force to pierce the vials with the risk of microparticles being released from the plastic rubber protecting the vial into the dilution.Other comments: administering a solution of medication with plastic or glass particles from the vials.On the other hand, the following information is requested: - incidents and/or complaints that have occurred in spain of which you have had knowledge related to the product.- if this product has been involved in an fsca.- units of the aforementioned product distributed in spain in the last 3 years.- number of units distributed in europe and worldwide in the last 3 years.- whether they have contacted the site to request the product involved in the incident or to have access to it for further information.In accordance with article 87(11) of regulation (eu) 2017/745 on medical devices, this incident is brought to your attention so that you can urgently refer it to the manufacturer of the device and initiate an investigation.They should send us the initial report including in it our reference for this dossier (ps/mjf/102105) keep us informed of the progress of the investigation related to this incident and send us the final report with the results of the investigation and possible corrective actions.This incident report has been assigned the reference ps/mjf/102105, to which you are kindly requested to refer in case of forwarding any information related to this incident.Thank you very much yours faithfully.
Additional Manufacturer Narrative
(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.H3 other text : see h10 manufacture narrative.
Event or Problem Description
No additional information received.Good morning, we have received in the area of surveillance of medical devices of the spanish agency of medicines and medical devices, notification from the health professional sergio ganbo (with email sergio.Bango@sespa.Es ), regarding an incident with the medical device bd blunt fill needle, model 18g x 1 tw (1.2mm x 25 mm), serial number unknown, lot number 3086629, occurred on (b)(6) 2024, in the c.S severo ochoa, gijón, asturias.The information provided is as follows: description of the incident: the medication loading needle described is not safe for medication preparation as although it minimises the risk of puncture, the blunt tip requires exerting more force to pierce the vials with the risk of microparticles being released from the plastic rubber protecting the vial into the dilution.Other comments: administering a solution of medication with plastic or glass particles from the vials.On the other hand, the following information is requested: incidents and/or complaints that have occurred in spain of which you have had knowledge related to the product.If this product has been involved in an fsca.Units of the aforementioned product distributed in spain in the last 3 years.Number of units distributed in europe and worldwide in the last 3 years.Whether they have contacted the site to request the product involved in the incident or to have access to it for further information.In accordance with article 87(11) of regulation (eu) 2017/745 on medical devices, this incident is brought to your attention so that you can urgently refer it to the manufacturer of the device and initiate an investigation.They should send us the initial report including in it our reference for this dossier (ps/mjf/102105) keep us informed of the progress of the investigation related to this incident and send us the final report with the results of the investigation and possible corrective actions.This incident report has been assigned the reference ps/mjf/102105, to which you are kindly requested to refer in case of forwarding any information related to this incident.Thank you very much, yours faithfully.
Additional Manufacturer Narrative
Pr 9599078 follow up.A device history record review was completed by our quality engineer team for provided material number 305181 and lot number 3086629.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.

• Brand Name: NEEDLE 18X1IN BLUNT FILL
• Common Device Name: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18684485
• Report Number: 1911916-2024-00075
• Device Sequence Number: 20641409
• Product Code: GAA
• UDI-Device Identifier: 30382903051817
• UDI-Public: (01)30382903051817
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 305181
• Device Lot Number: 3086629
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2024
• Supplement Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 02/12/2024
• Supplement Report FDA Received Date: 02/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown