MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 30X1 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305128
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
Material#: 305128, batch#: 3024960.It was reported by the customer that they have 30g needle broke off in patient.Rcc received a complaint via email.Email(s) attached.We were notified of a complaint from a customer stating needle 30g broke off in patient.If it is indicated that a sample is available please provide shipping instructions within 30 days or the sample will be disposed of.Vendor part #: 305128 lot number #: 3024960 additional information received on 02-may-2024 how was the needle removed from patient? not specified when does this event happened? i.E.Date of event? (b)(6) 2024.Was there any procedure required for removal of needle? not specified how was the patient outcome? patient is doing good and there was no harm was the procedure carried out by a registered health practitioner? yes please provide address of the facility where the incident has occurred.It was noted that there is a sample available for investigation could you please provide the address where the sample is available for investigation?.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.It was reported the needle broke off in a patient.To aid in the investigation, one sample with no packaging blister and one photo was provided for evaluation by our quality team.A visual inspection was performed.First, with 10x magnification, and then with 30x magnification.The needle hub has only part of the needle that goes inside the hub.The top part of the needle is deformed as if it was bent before it broke.The photo provided shows the sample received.No other defects or imperfections were observed.This defect could occur if the needle was bent before breaking.A device history record review was completed for provided material number 305128, lot 3024960.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.
Event or Problem Description
No additional information received.Material#:305128 batch#: 3024960.It was reported by the customer that they have 30g needle broke off in patient.Verbatim: rcc received a complaint via email.Email(s) attached.We were notified of a complaint from a customer stating needle 30g broke off in patient.If it is indicated that a sample is available please provide shipping instructions within 30 days or the sample will be disposed of.Vendor part #: 305128.Lot number #: 3024960.Additional information received on 02-may-2024.¿ how was the needle removed from patient? not specified ¿ when does this event happened? i.E.Date of event? 3/28/2024 ¿ was there any procedure required for removal of needle? not specified ¿ how was the patient outcome? patient is doing good and there was no harm ¿ was the procedure carried out by a registered health practitioner? yes ¿ please provide address of the facility where the incident has occurred.¿ it was noted that there is a sample available for investigation could you please provide the address where the sample is available for investigation?.

• Brand Name: NEEDLE 30X1 RB
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• 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: 19248034
• Report Number: 1911916-2024-00318
• Device Sequence Number: 7332629
• Product Code: FMI
• UDI-Device Identifier: 30382903051282
• UDI-Public: (01)30382903051282
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 305128
• Device Lot Number: 3024960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2024
• Supplement Date Received by Manufacturer: 06/03/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown