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

Catalog Number 405211

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/17/2022

Event Type  malfunction  

Event Description

It was reported that the bd¿ long length spinal needle with quincke bevel broke from the hub when removing it from the patient.The following information was provided by the initial reporter, translated from french: "scanno-guided infiltration performed.Needle fractured on removal: metallic foreign body in soft tissue with tip in contact with roots.Clinical consequences: in the aftermath: normal clinical examination, no deficit.No complaints.Explanations given to the patient afterwards: instructions to reconsult in case of increased pain.".

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 16-nov-2022.H6: investigation summary: one physical sample was provided to our quality team for investigation and while the packaging corresponds to the material reported, the physical sample does not correspond to that item number.A device history review was performed for the reported lot 0097757 and no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Based on our investigation, we cannot identify a definitive root cause at this time.H3 other text : see h10.

Event Description

It was reported that the bd¿ long length spinal needle with quincke bevel broke from the hub when removing it from the patient.The following information was provided by the initial reporter, translated from french: "scanno-guided infiltration performed.Needle fractured on removal : metallic foreign body in soft tissue with tip in contact with roots.Clinical consequences: in the aftermath: normal clinical examination, no deficit.No complaints.Explanations given to the patient afterwards: instructions to reconsult in case of increased pain.".

• Brand Name: BD¿ LONG LENGTH SPINAL NEEDLE WITH QUINCKE BEVEL
• Type of Device: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15794809
• MDR Text Key: 306782507
• Report Number: 2618282-2022-00074
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K210978
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 405211
• Device Lot Number: 0097757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1