MAUDE Adverse Event Report: BD (CAREFUSION 2200, INC) V. MUELLER; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number BE8230

Device Problem Detachment Of Device Component (1104)

Patient Problems Discomfort (2330); Foreign Body In Patient (2687)

Event Date 09/13/2016

Event Type  malfunction  

Event Description

Patient experienced retention of a 6 cm needle sheath of a 22ga mediastinoscopy aspirating needle.The 6 cm sheath is a sliding piece over the needle.When the needle was inserted during a surgical case performed approximately 7 months ago, the sliding piece was retained.Needle was used to inject local anesthetics.The patient was discharged to home, but later reported discomfort.X-rays confirmed metallic object.Patient returned to have the object removed approximately one month ago.

• Brand Name: V. MUELLER
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BD (CAREFUSION 2200, INC); 5859 farinon dr.; ste. 200; san antonio TX 78249
• MDR Report Key: 6544420
• MDR Text Key: 74438129
• Report Number: 6544420
• Device Sequence Number: 0
• Product Code: DWO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: BE8230
• Device Catalogue Number: BE8230
• Other Device ID Number: 22GA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/26/2017
• Event Location: Hospital
• Date Report to Manufacturer: 04/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO.
• Patient Outcome(s): Other
• Patient Age: 42 YR