MAUDE Adverse Event Report: BD BD WHITACRE PENCIL PONIT SPINAL NEEDLE SET 27G

Catalog Number 405113

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Test Result (2695); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

The patient was undergoing spinal anesthesia in preparation to give birth to her child.A 27g bd whitacre needle was used for this procedure.It is reported that bony resistance was encountered during the needle insertion and after 2-3 attempts it was decided to change the spinal needle.As the needle was withdrawn from the patient it was noticed that approximately 2 cm of the tip of the needle was missing.Another attempt was made with a different needle and spinal anesthesia was performed successfully.After the patient delivered her baby, a portable x-ray of the patient's lumbar spine was done revealing the broken spinal needle at the level of the patient sl3 vertebrae.A ct scan of the patient's lumbar spine was done the next day which showed the retained needle fragment in the patient's paravertebral muscle, behind the lateral to the spinous process of the l3 vertebrae.The patient then had a consultation with a spinal surgeon who reassured her that the retained fragment will not cause any harm and that they would discuss its removal in a follow up appointment.

Manufacturer Narrative

The device is not available for evaluation.A review of the device history records could not be performed as a lot number for this incident was not provided.Conclusion: without a sample, a root cause for this incident could not be determined.

• Brand Name: BD WHITACRE PENCIL PONIT SPINAL NEEDLE SET 27G
• Type of Device: SPINAL NEEDLE
• Manufacturer (Section D): BD; 1 becton dr.; franklin lakes NJ 07417 188
• Manufacturer (Section G): CAMINO DE VALDEOLIVA; 28750 san agustin de guadalix; SP
• Manufacturer Contact: aaron larson ; 1 becton dr.; franklin lakes, NJ 07417-1880 ; 8015652406
• MDR Report Key: 4176650
• MDR Text Key: 5027200
• Report Number: 2243072-2014-00208
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: SA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 405113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention