MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD SYRINGE 3ML LL W/NDL ECLIPSE¿ 25X5/8 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305781
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma / 510(k)#: k980987(syringe); 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 prior to use foreign matter was discovered when plunger was pulled back with a bd syringe 3ml ll w/ndl eclipse¿ 25x5/8 rb.The following information was provided by the initial reporter: (1 of 2).It was reported that when the plunger is pulled back you can see a ring of condensation where the plunger was at.
Additional Manufacturer Narrative
Investigation summary: 5 actual samples in sealed package were received for evaluation.A bd quality engineer inspected the returned units and identified a ring of silicone inside the syringes when the plungers were pulled back.All five samples were subjected to the silicone content test and passed.The silicone content was determined to be within specification.A device history record review showed no non-conformance's associated with this issue during the production of this batch.Customer complaint trends are evaluated on a monthly basis.If the trend of a specific type of complaint warrants corrective action, resources will be assigned at that time.
Event or Problem Description
It was reported that prior to use foreign matter was discovered when plunger was pulled back with a bd syringe 3ml ll w/ndl eclipse¿ 25x5/8 rb.The following information was provided by the initial reporter: (1 of 2) it was reported that when the plunger is pulled back you can see a ring of condensation where the plunger was at.

• Brand Name: BD SYRINGE 3ML LL W/NDL ECLIPSE¿ 25X5/8 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8819388
• Report Number: 8041187-2019-00561
• Device Sequence Number: 2838310
• Product Code: FMI
• UDI-Device Identifier: 30382903057819
• UDI-Public: 30382903057819
• 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
• 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): 08/14/2019

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: 03/31/2023
• Device Catalogue Number: 305781
• Device Lot Number: 8082119
• Initial Date Received by Manufacturer: 07/09/2019
• Supplement Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 08/14/2019
• 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