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

Catalog Number	305127
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Material#: 305127, batch#: unknown (provided lot#: 381232).Rcc received a complaint via email.The needle broke off the hub and was lodged in the patient during use.Interventional radiology tried to retrieve the needle and was unsuccessful.Surgery was consulted.The decision was made not to surgically remove the needle.1.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.Unknown, the needle broke off the hub and was lodged in the patient during use.2.Can you please provide the lot number associated with reported issue? given lot#: 381232 not valid.25g 1 1/2 inch precision glide needle this is a needle that we use to deliver lidocaine to a patient during a procedure.It comes in our pre-made sterile angioplasty packs.The current lot# for these packs is 381232.Catalog: san30agsbd from cardinal health.3.Total number of occurrences? unknown.4.Any sample or photo available for investigation? no, if yes, are you able to provide the address of the facility for us to ship the return label?.
Additional Manufacturer Narrative
Initial mdr submission.Investigation summary: it was reported the needle broke off the hub.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.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

• 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: 21133535
• Report Number: 1911916-2025-00010
• Device Sequence Number: 12658115
• Product Code: FMI
• UDI-Device Identifier: 30382903051275
• UDI-Public: (01)30382903051275
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 12/31/2024
• Initial Report FDA Received Date: 01/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown