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

Catalog Number 405079

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/05/2019

Event Type  Injury  

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 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 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.

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
• Type of Device: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 9106710
• MDR Text Key: 163983138
• Report Number: 2618282-2019-00252
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 30382904050796
• UDI-Public: 30382904050796
• Combination Product (y/n): N
• PMA/PMN Number: K091758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Other
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 405079
• Device Lot Number: 9011708
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/05/2019
• Initial Date FDA Received: 09/23/2019
• Supplement Dates Manufacturer Received: 09/05/2019
• Supplement Dates FDA Received: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR