MAUDE Adverse Event Report: BD CARIBE LTD. NEEDLE SPINAL S/SU 27GA 3-1/2IN WHITACRE; ANESTHESIA CONDUCTION NEEDLE

Catalog Number	405079
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It has been reported that one needle spinal s/su 27ga 3-1/2in whitacre has been found with the needle breaking during use.The following has been provided by the initial reporter: patient who presents spinal needle fracture at the time of spinal anesthesia.Required: neurosurgeon evaluation, position with fluoroscope is verified, incision is made, the fragment is removed and skin is sutured.The hospital stay is not prolonged or the patient's initial management plan is changed.He leaves the institution on the same day and informs the patient and family of the event.
Event or Problem Description
It has been reported that one needle spinal s/su 27ga 3-1/2in whitacre has been found with the needle breaking during use.The following has been provided by the initial reporter: patient who presents spinal needle fracture at the time of spinal anesthesia.Required: neurosurgeon evaluation, position with fluoroscope is verified, incision is made, the fragment is removed and skin is sutured.The hospital stay is not prolonged or the patient's initial management plan is changed.He leaves the institution on the same day and informs the patient and family of the event.
Additional Manufacturer Narrative
H.6.Investigation summary: bd has not been provide photos or samples for catalog 405079 lot 9011708 to investigate for this record.As a result, bd was unable to verify the reported issue or determine a definitive root cause.After reviewing the device history records, materials, processes, and procedures, no non-conformances or changes were identified as it relates to the needle manufacturing process.Since no sample was received for evaluation, dhrs, materials, process and procedures were assessed.1.Material - complaint lot used during the assembly cannula mater 031940 lot 8219955, 8219950 and 8065905.Incoming inspection records were verified for these cannulas lots and inspections were executed as expected during the receiving of the lot.The drawing and specification for the cannula were verified and no changes in the cannula material were performed.2.Machin/equipment - device history record review for the lot numbers impacted was performed and no non-conformances impacting potential spinal needle cannula breakage were observed.All the inspections were performed as established per procedures with satisfactory results.Thus, preventive maintenance and instrument calibration were in compliance.3.Process/methods/procedure - no changes regarding manufacturing or inspection process / methods/ procedures of the affected components in the last years.Conclusion: bd juncos was not able to confirm that the customer's indicated failure mode is associated with the manufacturing processes.H3 other text : see section h.10.

• Brand Name: NEEDLE SPINAL S/SU 27GA 3-1/2IN WHITACRE
• Common Device Name: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 9106710
• Report Number: 2618282-2019-00252
• Device Sequence Number: 16614001
• Product Code: BSP
• UDI-Device Identifier: 30382904050796
• UDI-Public: 30382904050796
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K091758
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2019

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: Other
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 405079
• Device Lot Number: 9011708
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/05/2019
• Supplement Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 09/23/2019
• Supplement Report FDA Received Date: 10/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR