MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD LUER-LOK SYRINGE WITH BD ECLIPSE SAFETY THIN WALL 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	04/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple pma / 510(k)#s reported to be involved.The information for each 510(k) number is as follows: pma / 510(k)#: k980987.(syringe) pma / 510(k)#: k161170.(needle) 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 blood-like foreign matter was seen on the bd luer-lok¿ syringe with bd eclipse¿ safety thin wall needle inside the sealed packaging.The following information was provided by the initial reporter: "staff at the covid vaccination clinic grabbed a 3ml syringe/needle combo pack to use and noted there was what looked like blood on the luer end of the needle.The package was sealed and remains sealed.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: device available for eval yes.Returned to manufacturer on: 2021-05-10.Investigation summary: two photos and one sample in sealed packaging were received by our quality team for evaluation.From the photos, a reddish-brown stain-like foreign matter was observed on the eclipse hub.The sample was subjected to visual inspection to check for foreign matter, and a dark brown liquid-type foreign matter was observed on the surface of the eclipse hub and on the bottom web.The foreign matter was sent for ftir testing to determine the foreign matter type and the results show that the spectrum matches reasonably with that of a phthalate ester compound.After testing the oven oil against this foreign matter, it was concluded that the dark brown liquid-type foreign matter could be the oven oil from the assembly machine.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.The probable cause of this foreign matter could be that there is a leakage from the exhaust pipe which resulted in the oven oil to be dripped down to the machine cover and seeped through the machine cover gaps and landed on the eclipse hub surface.The exhaust pipe was replaced after this batch was produced, and the current pipe is verified and no leakages have been observed.
Event or Problem Description
It was reported that blood-like foreign matter was seen on the bd luer-lok¿ syringe with bd eclipse¿ safety thin wall needle inside the sealed packaging.The following information was provided by the initial reporter: "staff at the covid vaccination clinic grabbed a 3ml syringe/needle combo pack to use and noted there was what looked like blood on the luer end of the needle.The package was sealed and remains sealed.".

• Brand Name: BD LUER-LOK SYRINGE WITH BD ECLIPSE SAFETY THIN WALL NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 11845995
• Report Number: 8041187-2021-00422
• Device Sequence Number: 11568974
• Product Code: FMI
• UDI-Device Identifier: 30382903057871
• UDI-Public: 30382903057871
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: SEE H.10.
• 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): 06/03/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1