MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ECLIPSE¿ NEEDLE

Catalog Number	305767
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device lot #: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that during use a bd eclipse ¿ needle the needle broke.The consumer stated "needle broke mid needle, during dry needling technique where needle was used to enter muscle and moved back and forth and up and down to relieve muscle spasms¿ there is no further information regarding medical intervention required or injury.
Additional Manufacturer Narrative
additional information was received for the medical device lot number(s).  the following field(s) have been updated: medical device lot #:4232148.Medical device expiration date: 08/31/2019.Device manufacture date: 08/20/2014.
Additional Manufacturer Narrative
Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.Dhr review shows no similar complaint being reported on the affected batch according to the complaint database.No abnormality or quality notification reported on the affected batch during production.The preventive maintenance, calibration and equipment checks showed no abnormality that could have influenced the issue.If samples are received in the future the complaint will be re-opened and re-investigated.

• Brand Name: BD ECLIPSE¿ NEEDLE
• Common Device Name: NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 7388916
• Report Number: 8041187-2018-00096
• Device Sequence Number: 1031205
• Product Code: FMI
• UDI-Device Identifier: 00382903057672
• UDI-Public: 00382903057672
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K161170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/26/2018

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?: Yes
• Operator of Device: Other
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 305767
• Device Lot Number: 4232148
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/23/2018
• Supplement Date Received by Manufacturer: 03/23/2018; 03/23/2018
• Initial Report FDA Received Date: 04/02/2018
• Supplement Report FDA Received Date: 04/03/2018; 05/08/2018
• 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