MAUDE Adverse Event Report: BECTON DICKINSON TRAY SPN WHIT27G3.5 L/B-D/E; ANESTHESIA CONDUCTION KIT

Catalog Number	405699
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Material#: 405699, batch#: 0001538207.Broken during use inside patient."they were broken before use.Right out of package." additional info received 13mar2025: could you please provide a further description of the issue what is broken refer to (package or product)? 27g whitacre spinal needle 3.5 in.Broken during use inside patient.Can you please provide the material and lot number associated with reported issue? don't have packaging anymore.Total number of occurrences? 3 within a year.Sample available is mentioned as yes, are you able to provide the address of the facility for us to ship the return label? no longer available.If possible, provide the picture samples.Non-available.On (b)(6) 2025: per customer reply: i¿m not sure of the reference numbers.Maybe (b)(6) can help out with that.But yes, this is at least the 3rd broken spinal needle we've had of yours within a year.All previously reported.I¿m not sure of the reference numbers.Further communication from customer on (b)(6) 2025: the needles broke in the patients, the glass tip of the syringes were not in the patient.Two of the broken spinal needles needed to be retrieved by radiology.One came out because it was still partially attached to the rest of the needle.
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.
Additional Manufacturer Narrative
Pr (b)(4) follow up mdr for device evaluation: no photos or physical samples that display the reported condition were available for investigation.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001538207 was performed and no recorded quality problems or rejections related to this incident were found.Product undergoes inspections during manufacturing, no issues related to the reported incident were identified, all procedural and functional requirements for product release have been met.The needle within this kit is provided by a supplier site whom we have notified the supplier of this incident.Based on the available information we are not able to identify a root cause at this time.To date, there have been no other similar events reported for this lot.Complaints received for this device and reported condition will continue to be monitored by our quality team for signs of emerging trends.
Event or Problem Description
No additional information.

• Brand Name: TRAY SPN WHIT27G3.5 L/B-D/E
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21752660
• Report Number: 1625685-2025-00029
• Device Sequence Number: 9700995
• Product Code: CAZ
• UDI-Device Identifier: 00382904056995
• UDI-Public: (01)00382904056995(11)231017(17)251031(10)0001538207
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• 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): 04/02/2025

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 Expiration Date: 10/31/2025
• Device Catalogue Number: 405699
• Device Lot Number: 0001538207
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2025
• Supplement Date Received by Manufacturer: 04/02/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2023
• 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