MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ECLIPSE¿ NEEDLE 27 G X 1/2 IN. WITH DETACHABLE 1 ML BD LUER-LOK¿ SYRINGE; PISTON SYRINGE

Model Number	305789
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	02/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd eclipse¿ needle 27 g x 1/2 in.With detachable 1 ml bd luer-lok¿ syringe foreign matter was found in the fluid pathway.There was no report of patient impact.The following information was provided by the initial reporter: material no: 305789 batch no: 1204099 customer can see some sort of oily liquid inside the barrels of the needle/syring combo packages.
Additional Manufacturer Narrative
A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.There were multiple 510k numbers reported to be involved.The information for the additional 510k is as follows: 510k#: k161170.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 29-mar-2022.H.6.Investigation: two photos, one sample with open packaging, and five representative samples were received by our quality team for evaluation.From the photos, an oily liquid was observed inside the syringe barrel.The six samples were subjected to visual inspection to check for foreign matter inside the barrel.All samples were observed with excessive lubricant on the 1ml plunger instead of inside the barrel.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.There were no abnormalities observed during the production of the affected batches.The packaging line was reviewed and there is no lubricant (silicone) used at the line.The 1ml syringe part is manufactured from bd canaan.The quality team at bd canaan has performed a supplemental investigation on this nonconformance.The team visually evaluated the samples, and each sample was observed to have a sticky substance outside of the fluid path, on the flange, and coated on the plunger.The substance observed appeared to be a silicone lubricant used in the assembly process.The inspection procedures, production records and technician logs were reviewed, the process engineer was interviewed, and an in-depth machine evaluation was performed as part of this investigation.No issues around the silicone system were noted in the production records or the technician logs.The silicone gun on the machine was observed to have excessive play.The ideal set-up is a gun held to the backing plate of the assembly dial.At the time of the review, the gun was able to slide laterally about a quarter of an inch.It was also observed that the silicone gun purge function was directly accessible on the human-machine interface that operators handle daily.This function expels air and silicone from the gun and its associated hose.This is a function that should only be accessible to authorized technicians as misuse can lead to quality issues around siliconization, especially if machine dials are not cleaned post purging, or removed prior to purging.The adjustment procedure for the silicone system also did not capture post-adjustment qualifications for the silicone gun purge function.Ensuring the assembly system is clean of excess lubricant is essential in ensuring quality product post purge.A trial was performed on the machine to replicate the defect.It was noted that the machine would run while the gun was in a purge state.Additionally, it was found that after purging the silicone gun and not properly cleaning the machine dials before returning to production the complaint defect would occur.The potential root causes for the excessive silicone defect were determined to be improper positioning of the silicone gun leading to overspray on the barrel flanges and the machine dial, excessive silicone presence due to the misuse of the silicone gun purge function, inadequate capture and confliction in inspection procedures for silicone outside of the fluid path, and improper adjustment requirements for silicone purge function.H3 other text : see h.10.
Event or Problem Description
It was reported while using bd eclipse¿ needle 27 g x 1/2 in.With detachable 1 ml bd luer-lok¿ syringe foreign matter was found in the fluid pathway.There was no report of patient impact.The following information was provided by the initial reporter: material no: 305789; batch no: 1204099.Customer can see some sort of oily liquid inside the barrels of the needle/syring combo packages.

• Brand Name: BD ECLIPSE¿ NEEDLE 27 G X 1/2 IN. WITH DETACHABLE 1 ML BD LUER-LOK¿ SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13625277
• Report Number: 8041187-2022-00102
• Device Sequence Number: 17408308
• Product Code: FMF
• UDI-Device Identifier: 30382903057895
• UDI-Public: 30382903057895
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K941562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2022

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: 07/31/2026
• Device Model Number: 305789
• Device Catalogue Number: 305789
• Device Lot Number: 1204099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2022
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 02/28/2022
• Supplement Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown