MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; NEEDLE IN CSMC SHOULDER PACK

Catalog Number DYNJ0665368B

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/20/2017

Event Type  Injury  

Manufacturer Narrative

Multiple attempts were made to contact the account to obtain additional details.The original notification stated a "needle broke off into the patient arm".It is unknown how the needle was being used, how the needle broke, or where in the arm the needle broke.It is unknown how the needle was removed from the patients arm.The sample was returned but a root cause cannot be determined.Due to the reported incident and in an abundance of caution this medwatch is being filed.

Event Description

It was reported a needle broke off into a patients arm.

• Type of Device: NEEDLE IN CSMC SHOULDER PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: megan debus ; three lakes drive; northfield, IL 60093
• MDR Report Key: 6575921
• MDR Text Key: 75463107
• Report Number: 1423395-2017-00015
• Device Sequence Number: 1
• Product Code: OJH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ0665368B
• Device Lot Number: 16FR0624
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 04/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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