MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD LUER-LOK¿ SYRINGE WITH DETACHABLE BD ECLIPSE¿ NEEDLE; 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	01/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 2 bd luer-lok¿ syringes with detachable bd eclipse¿ needle had brown foreign matter inside them.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "2 syringes look like there is some kind of brown substance on the inside,".
Additional Manufacturer Narrative
There were multiple medical device types reported to be involved.The information for the additional device type is as follows: common device name: hypodermic single lumen needle.Medical device type: fmi.There were multiple pma / 510(k)#s reported to be involved.The information for each 510(k) number is as follows: pma / 510(k)#: k941562 (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 2 bd luer-lok¿ syringes with detachable bd eclipse¿ needle had brown foreign matter inside them.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "2 syringes look like there is some kind of brown substance on the inside,".
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: 2/9/2022.Investigation: five samples without packaging and two empty unit packages were received by our quality team for evaluation.The samples were subjected to visual inspection to check for foreign matter and scale marking issues.From the returned samples, two samples were observed with brown embedded foreign matter, one sample was observed with a missing scale marking, one sample was observed with void / bubbles in the syringe barrel, and one sample with no abnormalities.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.As the syringe part is manufactured at bd canaan, the quality team there completed a supplemental investigation.After visual evaluation of the samples, the two samples were observed with embedded brownish / yellow foreign matter on several areas of the barrel.The foreign matter appears to be degraded plastic.One sample was observed to have several embedded air bubbles near the collar of the syringe.One sample was missing nearly the entirety of the printed scale with only the verbiage, bd logo, and single use only symbol present.The final sample appeared to have a jammed stopper which was angled up towards the barrel flange.The observed conditions were all non-conforming per product.The potential root cause for the embedded foreign matter defect is associated with the molding process.The embedded foreign matter is most likely degraded plastic, which occurs when the resin is exposed to prolonged high temperatures inside the molding machine, such as during start up.The potential root cause for the jammed stopper defect is associated with the assembly process.The potential root cause for the missing print defect is associated with the marking process.

• Brand Name: BD LUER-LOK¿ SYRINGE WITH DETACHABLE BD ECLIPSE¿ NEEDLE
• 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: 13470620
• Report Number: 8041187-2022-00068
• Device Sequence Number: 3886506
• Product Code: FMF
• UDI-Device Identifier: 30382903057895
• UDI-Public: 30382903057895
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H10
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 02/25/2022

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: 01/24/2022
• Supplement Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 02/07/2022
• Supplement Report FDA Received Date: 03/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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