MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD¿ SYRINGE LL W/NDL ECLIPSE RB; SAFETY SYRINGE

Catalog Number	305789
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional medical device type: fmf.Lot # 7293230 was provided, but it could not be found the database.Medical device expiration date: unknown.Device manufacture date: unknown.Additional pma / 510(k)# k161170.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 a bd¿ syringe ll w/ndl eclipse rb could not eject all the substance out.The following information was provided by the initial reporter: "customer noticed the bd syringe was not expelling all the substance out, and is concerned.Sales rep was provided a sample to return to medical mart.".
Event or Problem Description
It was reported that a bd¿ syringe ll w/ndl eclipse rb could not eject all the substance out.The following information was provided by the initial reporter: ¿ customer noticed the bd syringe was not expelling all the substance out, and is concerned.Sales rep was provided a sample to return to medical mart.¿.
Additional Manufacturer Narrative
Investigation: 1 actual unused sample without packaging was returned for investigation.The sample was not decontaminated.The sample was subjected to visual inspection to check on clogged needles.The sample was found with clogged needles.The sample was challenged at the automated vision system at the eclipse needle assembly line.Sample found with clogged needles from the visual inspection was able to be detected and rejected by the vision system.Return samples that was identified to be clogged are able to be detected and rejected by the vision system.The probable cause for parts not rejected is due to slanted rack pin.The slanted rack pin would result in the reject cylinder unable to completely reject the identified clogged needles resulting in the escape of the non-conformance part.Dhr was performed and there were no clogged needle rejects at the in-process and outgoing inspection.There were no quality notifications raised for the past 12 months on a similar reported defect.
Additional Manufacturer Narrative
Additional information: medical device lot #: 7293230.Medical device expiration date: 2022-10-31.Device manufacture date: 2017-10-20.
Event or Problem Description
It was reported that a bd¿ syringe ll w/ndl eclipse rb could not eject all the substance out.The following information was provided by the initial reporter: ¿ customer noticed the bd syringe was not expelling all the substance out, and is concerned.Sales rep was provided a sample to return to medical mart.¿.

• Brand Name: BD¿ SYRINGE LL W/NDL ECLIPSE RB
• Common Device Name: SAFETY SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8487686
• Report Number: 8041187-2019-00282
• Device Sequence Number: 16501931
• Product Code: FMI
• 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
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 305789
• Device Lot Number: 7293230
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 03/27/2019; 03/27/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 04/17/2019; 05/06/2019
• 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