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	07/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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: lot # 9361589, ref# 305758.Issue: we have recently had a few incidents where an rn is administering an immunotherapy injection and the needle remains in the patient, and disengages from bd 1ml tb syringe.Exchanging the 26g needle that comes on the 1ml tb syringe, with the 27g needle is our usual practice in allergy.There hasn't been an issue with this until recently, and it is concerning, as the patient does not receive the appropriate dose of immunotherapy ordered, and this could potentially harm the patient and/or caregiver.After a fellow rn spoke with other departments, apparently this has been happening on occasion.We originally intended to contact your company, to see if there was a problem with this specific lot # (9361589) of needles, to notify you of these events, and inquire if other customers are having similar issues.Upon further investigation, we noticed the 27g needles we have been placing on the tb syringes are to be used with luer lock syringes only.We believe this occurred because we of the type of syringe we were using.If you would still like a sample to investigate the product, please let me know how to go about sending that.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.Per customer response: i believe it has occurred approximately 4 times, twice this month on (b)(6) 2020.
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.Based on the quality team's investigation, the root cause of this incident cannot be determined.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: lot # 9361589, ref# (b)(4) issue: we have recently had a few incidents where an rn is administering an immunotherapy injection and the needle remains in the patient, and disengages from bd 1ml tb syringe.Exchanging the 26g needle that comes on the 1ml tb syringe, with the 27g needle is our usual practice in allergy.There hasn't been an issue with this until recently, and it is concerning, as the patient does not receive the appropriate dose of immunotherapy ordered, and this could potentially harm the patient and/or caregiver.After a fellow rn spoke with other departments, apparently this has been happening on occasion.We originally intended to contact your company, to see if there was a problem with this specific lot # (9361589) of needles, to notify you of these events, and inquire if other customers are having similar issues.Upon further investigation, we noticed the 27g needles we have been placing on the tb syringes are to be used with luer lock syringes only.We believe this occurred because we of the type of syringe we were using.If you would still like a sample to investigate the product, please let me know how to go about sending that.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.Per customer response: i believe it has occurred approximately 4 times, twice this month on 7/17/2020.

• 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: 10411626
• Report Number: 8041187-2020-00487
• Device Sequence Number: 2809132
• Product Code: FMI
• UDI-Device Identifier: 30382903057581
• UDI-Public: 30382903057581
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K161170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2020

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: 07/23/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 08/14/2020
• Supplement Report FDA Received Date: 08/18/2020
• 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