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

Model Number	305758
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's address is unknown:  new jersey (nj), usa has been used as a default.  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 an unspecified number of bd eclipse¿ needles experienced the needle and syringe separating/spinning out during use.The following information was provided by the initial reporter: material no: 305758 batch no: 9361589.It was reported that when rn is administering an immunotherapy injection, the needle remains in the patient and the patient does not receive the appropriate dose ordered.After discussing this with management, we felt that it wasn't necessary to send samples in for investigation.As previously mentioned, the more we looked into this issue, we realized we could have been using the needles with a more compatible luer lock style syringe.Moving forward we would like to implement this, and expect that using the luer lock syringe would prevent any further malfunctions.I believe it has occurred approximately 4 times.(b)(6) 2020 for two different rn's.We believe this occurred because we of the type of syringe we were using.Our medical assistant just recently placed an order for the 1ml tb syringe with luer lock, so hopefully this problem will resolve itself.We are hopeful that changing the syringe will prevent this issue from happening in the future.
Additional Manufacturer Narrative
H.6.Investigation: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.H3 other text : see h.10.
Event or Problem Description
It was reported that an unspecified number of bd eclipse¿ needles experienced the needle and syringe separating/spinning out during use.The following information was provided by the initial reporter: material no: 305758 batch no: 9361589.It was reported that when rn is administering an immunotherapy injection, the needle remains in the patient and the patient does not receive the appropriate dose ordered.After discussing this with management, we felt that it wasn't necessary to send samples in for investigation.As previously mentioned, the more we looked into this issue, we realized we could have been using the needles with a more compatible luer lock style syringe.Moving forward we would like to implement this, and expect that using the luer lock syringe would prevent any further malfunctions.I believe it has occurred approximately 4 times (b)(6) 2020 for two different rn's.We believe this occurred because we of the type of syringe we were using.Our medical assistant just recently placed an order for the 1ml tb syringe with luer lock, so hopefully this problem will resolve itself.We are hopeful that changing the syringe will prevent this issue from happening in the future.

• Brand Name: BD ECLIPSE NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10418389
• Report Number: 8041187-2020-00497
• Device Sequence Number: 16830073
• Product Code: FMI
• UDI-Device Identifier: 30382903057581
• UDI-Public: 30382903057581
• 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): 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 12/31/2024
• Device Model Number: 305758
• Device Catalogue Number: 305758
• Device Lot Number: 9361589
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 08/17/2020
• Supplement Report FDA Received Date: 08/25/2020
• 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