MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) NEEDLE ECLIPSE 21X1 RB TW; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305764
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.The customer's address is unknown.(b)(6) usa has been used as a default.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that needle eclipse 21x1 rb tw had foreign matter on the shaft of the needle.This was discovered during use.The following information was provided by the initial reporter: material no.: 305764, batch no.: 9084948.It was reported that the shaft of the needle was covered in a white plastic-like material.Verbatim: we recently had an issue with one of our eclipse needles.The shaft of the needle was covered in a white plastic-like material.Unfortunately, the phlebotomist had not performed a safety check to inspect the needle before use.She inserted the bevel of the needle, noticed the issue, then removed the needle.
Additional Manufacturer Narrative
H.6.Investigation summary three photos were received by our quality team for evaluation.Upon visual inspection of the photos, no abnormality was observed on the epoxy of the eclipse product; however, additional epoxy on the top and middle portion of the cannula was observed.The incident could be verified.A device history record review found no non-conformances associated with this issue during production of this batch.Additional epoxy on the top and middle portion of the cannula could be due to the epoxy being transferred to the product from the neighboring rack during the assembly process.There could have been a rack that toppled which would have caused the uncured epoxy to be deposited onto the product at the neighboring rack.The production technician may have cleared the toppled rack but did not remove the affected rack with deposited epoxy.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that needle eclipse 21x1 rb tw had foreign matter on the shaft of the needle.This was discovered during use.The following information was provided by the initial reporter: material no.: 305764 batch no.: 9084948 it was reported that the shaft of the needle was covered in a white plastic-like material.Verbatim: we recently had an issue with one of our eclipse needles.The shaft of the needle was covered in a white plastic-like material.Unfortunately, the phlebotomist had not performed a safety check to inspect the needle before use.She inserted the bevel of the needle, noticed the issue, then removed the needle.

• Brand Name: NEEDLE ECLIPSE 21X1 RB TW
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9648158
• Report Number: 8041187-2020-00032
• Device Sequence Number: 2495279
• Product Code: FMI
• UDI-Device Identifier: 30382903057642
• UDI-Public: 30382903057642
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2020

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: 03/31/2024
• Device Model Number: 305764
• Device Catalogue Number: 305764
• Device Lot Number: 9084948
• Initial Date Received by Manufacturer: 01/10/2020
• Supplement Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 03/03/2020
• 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