MAUDE Adverse Event Report: BD CARIBE LTD. BD¿ LONG LENGTH SPINAL NEEDLE WITH QUINCKE BEVEL; ANESTHESIA CONDUCTION NEEDLE

Model Number	405211
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Headache (1880)
Date of Event	06/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that while using the bd¿ long length spinal needle with quincke bevel a csf leak occured in a patient.The following was received from the initial reporter: now i have a question on another topic.Last week, on the occasion of an epidural steroid infiltration, we had a complication of a csf leak in a patient.We use the bd quincke needle for this.In the guidelines, you always read about "atraumatic" needles, for bd, for example, the whitecare.When i look at the needles, however, i would assume that this is a needle exclusively for csf puncture.Can these needles also be used for epidural infiltration? the opening in front of the tip does not seem suitable to me.Or are there other "atraumatic" needles for epidural infiltrations? update 20jun2023: 1.Was there any patient impact/harm due to the csf leak? yes, a csf loss syndrome, the patient had a headache, could only lie down and could not go to work for 2 weeks.2.Has a special treatment/safety measure been implemented? yes, a blood patch epidural.Thank you in advance for your support.
Additional Manufacturer Narrative
Investigation summary since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.
Event or Problem Description
It was reported that while using the bd¿ long length spinal needle with quincke bevel a csf leak occured in a patient.The following was received from the initial reporter: now i have a question on another topic.Last week, on the occasion of an epidural steroid infiltration, we had a complication of a csf leak in a patient.We use the bd quincke needle for this.In the guidelines, you always read about "atraumatic" needles, for bd, for example, the whitecare.When i look at the needles, however, i would assume that this is a needle exclusively for csf puncture.Can these needles also be used for epidural infiltration? the opening in front of the tip does not seem suitable to me.Or are there other "atraumatic" needles for epidural infiltrations? update 20jun2023: 1.Was there any patient impact/harm due to the csf leak? yes, a csf loss syndrome, the patient had a headache, could only lie down and could not go to work for 2 weeks.2.Has a special treatment/safety measure been implemented? yes, a blood patch epidural.Thank you in advance for your support.

• Brand Name: BD¿ LONG LENGTH SPINAL NEEDLE WITH QUINCKE BEVEL
• Common Device Name: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos IA
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos IA
• Manufacturer Contact: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17240611
• Report Number: 2618282-2023-00051
• Device Sequence Number: 14767536
• Product Code: BSP
• UDI-Device Identifier: 30382904052110
• UDI-Public: (01)30382904052110
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K210978
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2023

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 Model Number: 405211
• Device Catalogue Number: 405211
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2023
• Supplement Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown