MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) NEEDLE ECLIPSE 25X1-1/2 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305767
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 25x1-1/2 rb pulled out of the hub.This was discovered before use.The following information was provided by the initial reporter: material no.:305767, batch no.: 9227492.It was reported that the needle fell out of the device.Per pir: with additional questions answered: did it only occur once? yes.Did it result in any needlestick injury? no.
Event or Problem Description
It was reported that needle eclipse 25x1-1/2 rb pulled out of the hub.This was discovered before use.The following information was provided by the initial reporter: material no.:305767 batch no.: 9227492 it was reported that the needle fell out of the device.Per pir: with additional questions answered: -did it only occur once? yes.-did it result in any needlestick injury? no.
Additional Manufacturer Narrative
H.6.Investigation: one actual sample was received by our quality team for evaluation.Upon visual inspection it was observed that the cannula was detached from the hub; therefore, the incident could be verified.Further evaluation was done and it was observed that no abnormality observed on the epoxy profile, that the cannula was observed to be broken from the tip of the epoxy, and that the broken end of the cannula showed a slight curvature and the fracture area observed to be uniform.A simulation was done to try and mimic the incident.The cannula was subjected to bending force to break the cannula at the tip of the epoxy.The cannula was able to be broken upon two times bending.It was observed that the cannula broke from the tip of the epoxy.The broken end of the cannula showed a slight curvature and the fracture area observed to be more uniform than the returned sample.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Based on the simulation, the cannula broke at the tip of epoxy and the broken end of the cannula showed a slight curvature.But the fracture area observed to be more uniform than the returned samples.It is likely the cannula could have been broke with an unknown bending force applied at the tip of the epoxy after the epoxy was cured.The assembly process was reviewed.The only contact area on the cannula was when the epoxy nozzle was applying epoxy horizontally to the cannula.The cannula is unlikely to be break by this process as the epoxy is still uncured.There is no other contact areas at the machine after the epoxy was cured that could break the cannula.There is also no bending motion in our machine to break the cannula.The cannula stiffness was reviewed and were within the specifications.Hence root cause could not be determined.Dhr was performed and there were no notifications related to the complaint.H3 other text : see h.10.

• Brand Name: NEEDLE ECLIPSE 25X1-1/2 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9836681
• Report Number: 8041187-2020-00148
• Device Sequence Number: 3296983
• Product Code: FMI
• UDI-Device Identifier: 30382903057673
• UDI-Public: 30382903057673
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 05/11/2020

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: 07/31/2024
• Device Model Number: 305767
• Device Catalogue Number: 305767
• Device Lot Number: 9227492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Initial Date Received by Manufacturer: 02/25/2020
• Supplement Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 05/11/2020
• 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