MAUDE Adverse Event Report: BECTON DICKINSON ULTRAFINE III NANO PEN NEEDLE 32G 4MM 5S

Catalog Number	320179
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	06/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that after use of the ultrafine iii nano pen needle 32g 4mm 5s as the nurse was walking holding the injection tray the nurse pricked her right index finger.The needle stick was from the none patient end of the needle.The following information was provided by the initial reporter: nurse trainee and staff nurse went into patient¿s room to administer subcutaneous insulin to the patient.After administering the insulin, nurse trainee put the capped needle into the injection tray and was walking back to the medication room to discard the insulin needle into sharp bin.While walking holding the injection tray, she felt a prick in her right index finger and she realized she got pricked by the needle which is at the back of the capped insulin needle.Nurse trainee inform staff nurse and she washed her finger under the running tap and applied plaster.
Additional Manufacturer Narrative
Investigation summary: one photo of an empty blue tray was returned.As no physical pen needle sample or a photo of a pen needle sample was returned no further investigation can be carried out.No dhr review can be carried out as lot number is unknown based on the above, no additional investigation and no corrective/preventative action (capa) is required at this time.
Event or Problem Description
It was reported that after use of the ultrafine iii nano pen needle 32g 4mm 5s as the nurse was walking holding the injection tray the nurse pricked her right index finger.The needle stick was from the none patient end of the needle.The following information was provided by the initial reporter: nurse trainee and staff nurse went into patient¿s room to administer subcutaneous insulin to the patient.After administering the insulin, nurse trainee put the capped needle into the injection tray and was walking back to the medication room to discard the insulin needle into sharp bin.While walking holding the injection tray, she felt a prick in her right index finger and she realized she got pricked by the needle which is at the back of the capped insulin needle.Nurse trainee inform staff nurse and she washed her finger under the running tap and applied plaster.

• Brand Name: ULTRAFINE III NANO PEN NEEDLE 32G 4MM 5S
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8921834
• Report Number: 2243072-2019-01794
• Device Sequence Number: 16620449
• Product Code: FMI
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: N/A
• 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): 08/30/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 320179
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 08/05/2019
• Supplement Date Received by Manufacturer: 08/05/2019
• Initial Report FDA Received Date: 08/22/2019
• Supplement Report FDA Received Date: 08/30/2019
• 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: Other