MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ECLIPSE¿ HINGED SAFETY NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305764
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that foreign material was found in the ¿needle capsule¿ of a bd eclipse¿ hinged safety needle.There was no report of exposure, injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: one actual sample was returned in sealed package for investigation.Loose black substance was observed on the inner surface of the needle shield.The fm was taken out and pressed onto a pellet for ftir sample preparation.Oil-like liquid was observed.The fm was subjected to ftir analysis.However, we are unable to identify the fm based on the ftir results.We are unable to identify the fm based on the ftir results.However, based on our observation, the fm is a compound of oil-like liquid and black particles.The only oil-like liquid used in the molding and assembly process is the oil used in the hydraulic pump of molding machine.There is no possibility of direct contact of the oil with the needle shield and there was no oil leakage reported according to our manufacturing record.After reviewed the entire manufacturing process, no possible source of the compound of oil and black particles could be found.A device history record review showed no non-conformances associated with this issue during the production of this batch.Investigation conclusion: the probable root cause of the black fm could be from the manufacturing environment.The nonconformance was not detected during inspection due to the low defective rate.This was most likely an isolated event.

• Brand Name: BD ECLIPSE¿ HINGED SAFETY NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 7496482
• Report Number: 8041187-2018-00144
• Device Sequence Number: 109470
• Product Code: FMI
• UDI-Device Identifier: 30382903057642
• UDI-Public: 30382903057642
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 05/22/2018

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: 03/31/2021
• Device Catalogue Number: 305764
• Device Lot Number: 6079226
• Initial Date Received by Manufacturer: 04/18/2018
• Supplement Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 05/08/2018
• Supplement Report FDA Received Date: 05/22/2018
• 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