MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 25X1-1/2 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305127
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2024
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#: 305127.Batch#: unknown.It was reported by the customer that needle broke off during a procedure and the surgeon was able to retrieve it with no harm to the patient.Verbatim: rcc received a complaint via email.Email(s) attached medication needle hypodermic 25 gage, 1.5-inch blue ¿ mfg# 305127 needle broke off during a procedure and the surgeon was able to retrieve it with no harm to the patient.Additional information: 1.Kindly provide the batch/lot number of the product.¿ product lot was not documented 2.Can you share any physical sample if available for investigation? if yes, please provide the address of the facility for us to ship the return label? ¿ product was disposed.3.If possible, could you please provide picture samples for investigation? no pictures were taken.
Additional Manufacturer Narrative
(b)(4) follow up : as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.There are current quality controls in place to detect this type of defect during the production process.Based on the limited investigation results, a cause for the reported incident could not be determined.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the product involved may provide clarification as to the cause for the reported failure.
Event or Problem Description
No additional information received material#: 305127 , batch#: unknown.It was reported by the customer that needle broke off during a procedure and the surgeon was able to retrieve it with no harm to the patient.Verbatim: rcc received a complaint via email.Medication needle hypodermic 25 gage, 1.5-inch blue ¿ mfg# (b)(4).Needle broke off during a procedure and the surgeon was able to retrieve it with no harm to the patient.Additional information: 1.Kindly provide the batch/lot number of the product.¿ product lot was not documented.2.Can you share any physical sample if available for investigation? if yes, please provide the address of the facility for us to ship the return label? ¿ product was disposed.3.If possible, could you please provide picture samples for investigation? no pictures were taken.

• Brand Name: NEEDLE 25X1-1/2 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: 20032098
• Report Number: 1911916-2024-00617
• Device Sequence Number: 3023866
• Product Code: FMI
• UDI-Device Identifier: 30382903051275
• UDI-Public: (01)30382903051275
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

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: 305127
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2024
• Supplement Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown