MAUDE Adverse Event Report: BD BD ULTRA FINE PEN NEEDLE; 31G 8MM

Catalog Number 3045260

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

On (b)(6) 2013, the reporter stated that patient was a (b)(6) old and was very skinny.The fourth day of application, when the mother was administering the product, the needle broke.She grabbed the leg to administer the injection in the thigh, the son stood reluctantly and moved a little.She continued the administration, removed the pen and realized at that time that the needle had broken.The child was taken to the emergency room and an x-ray was performed and revealed the presence of the needle in the leg.The next morning, the surgery was performed under general anesthesia.A radiography was performed to identify the location of the needle.The doctor made three small incisions to remove the needle with the aid of forceps.The procedure went well.On (b)(6) 2013, the dressing was removed, and the small incisions of 1 cm and the child were doing well.On an unknown date, the mother discontinued treatment with genotropin.

Manufacturer Narrative

(b)(4).No product has been received to date, if product is returned, analysis will be conducted.A complaint history check was performed and this is the first related complaint reported for the defect/condition on lot number 3045260.

• Brand Name: BD ULTRA FINE PEN NEEDLE
• Type of Device: 31G 8MM
• Manufacturer (Section D): BD; 1 becton dr.; franklin lakes NJ 07417
• Manufacturer (Section G): BD; pottery road; dun laoghaire, co dublin ; EI
• Manufacturer Contact: elizabeth closner, rn, bsn ; 1 becton dr.; franklin lakes, NJ 07417 ; 2105265165
• MDR Report Key: 3597024
• MDR Text Key: 4089649
• Report Number: 2243072-2014-00012
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/17/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2014
• Device Catalogue Number: 3045260
• Device Lot Number: 3045260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/02/2014
• Initial Date FDA Received: 01/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2013
• 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