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

Model Number	305787
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2021
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 a failure to contain blood/medication.The following information was provided by the initial reporter: material no:305787, batch no: 9234610.Cracks on bd 3 ml syringes, normal saline leaking on from cracks.Crack noted from 0.5ml-2.0 ml markings on one syringe.Crack noted from 0.2ml marking -1.4ml marking.Crack noted from 0.5ml marking -1.5ml marking.
Event or Problem Description
It was reported that the bd eclipse¿ needle experienced a failure to contain blood/medication.The following information was provided by the initial reporter: material no:305787; batch no: 9234610.Cracks on bd 3 ml syringes, normal saline leaking on from cracks.Crack noted from 0.5ml-2.0 ml markings on one syringe.Crack noted from 0.2ml marking -1.4ml marking.Crack noted from 0.5ml marking -1.5ml marking.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval?: yes.D10: returned to manufacturer on: 6/21/2021.H6: investigation: one photo, three samples without packaging, and one empty unit package was received by our quality team for evaluation.From the photo, the team was unable to observe the cracked barrel defect as only the top web packaging was provided.The samples were subjected to visual inspection to check for a cracked barrel.One crack line was observed on the surface on the surface of the syringe barrel for all three returned samples.A device history record review found no non-conformances associated with this issue during production of this batch.The syringe manufacturing process was reviewed.The crack line on the barrel could have occurred at the assembly machine.At this machine, there is a rotary main assembly dial during the transfer of the syringe product to the exerciser dial, the syringe may tilt and hit against the dial side guide resulting in a part being trapped or jammed.When there is a product trapped or jammed at the side guide, it results in the subsequent syringe to rub against the jammed product which caused cracked on the barrel body.H3 other text: see h10.

• 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: 12052713
• Report Number: 8041187-2021-00522
• Device Sequence Number: 14319007
• Product Code: FMI
• UDI-Device Identifier: 30382903057871
• UDI-Public: 30382903057871
• Combination Product (Y/N): Y
• 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): 07/30/2021

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: 06/21/2021
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 08/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1