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

Model Number	305787
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2021
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 the bd eclipse¿ needle experienced foreign matter in the device cannula/needle/syringe or other fluid path component.The following information was provided by the initial reporter: material no: 305787, batch no: 9234610.Pharmacist was immunizing in vaccine clinic, drew up vaccine dose from vial with 3 ml syringe and 5/8 needle, went to change needle to 1" before administration and noticed a brown sticky substance over the needle, the safety cover and inside the package.Vaccine dose had to be wasted because of this.
Additional Manufacturer Narrative
H6: investigation summary: no photos or samples were received by our quality team for evaluation.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 a similar complaint, the foreign matter could be determined to be a phthalate ester compound which matches with the oven oil from the assembly machine.The probable cause of the foreign matter could be that there were leakages from the exhaust pipe which resulted in the oven oil to be dripped down to the machine cover gaps and landed on the eclipse hub surface.The brown foreign matter could also have stained the eclipse shield and bottom web during subsequent processing.The exhaust pipe has been replaced and the current exhaust pipe is verified, and no leakages were observed.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
Event or Problem Description
It was reported that the bd eclipse¿ needle experienced foreign matter in the device cannula/needle/syringe or other fluid path component.The following information was provided by the initial reporter: material no: 305787, batch no: 9234610.Pharmacist was immunizing in vaccine clinic, drew up vaccine dose from vial with 3 ml syringe and 5/8 needle, went to change needle to 1" before administration and noticed a brown sticky substance over the needle, the safety cover and inside the package.Vaccine dose had to be wasted because of this.

• 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: 12094902
• Report Number: 8041187-2021-00547
• Device Sequence Number: 4752248
• Product Code: FMI
• UDI-Device Identifier: 30382903057871
• UDI-Public: 30382903057871
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2021

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: 07/31/2024
• Device Model Number: 305787
• Device Catalogue Number: 305787
• Device Lot Number: 9234610
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/02/2021
• Supplement Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 07/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1