MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) SYRINGE 3ML LL W/NDL ECLIPSE 25X1 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305787
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	04/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Pma/510(k)#: k980987(syringe); k161170 (needle).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that syringe 3ml ll w/ndl eclipse 25x1 rb had foreign matter.This occurred on 2 occasions.The following information was provided by the initial reporter: material no: 305787 batch no: unknown.It was reported that two syringes had crystals or something on the needle.Verbatim: we had another syringe issue.The staff at our outpatient clinic found two syringes that look like they have some type of crystals or something on the needle.They are the bd eclipse 3ml 25g x1.We do not know the lot number.No other issues with any of the other syringes have been noted.
Event or Problem Description
It was reported that syringe 3ml ll w/ndl eclipse 25x1 rb had foreign matter.This occurred on 2 occasions.The following information was provided by the initial reporter: material no: 305787 batch no: unknown it was reported that two syringes had crystals or something on the needle.Verbatim: we had another syringe issue.The staff at our outpatient clinic found two syringes that look like they have some type of crystals or something on the needle.They are the bd eclipse 3ml 25g x1.We do not know the lot number.No other issues with any of the other syringes have been noted.
Additional Manufacturer Narrative
H6: investigation summary two samples without packaging were received by our quality team for investigation.The samples were subjected to visual inspection and gel (silicone) on the cannula was observed.A device history record could not be evaluated as the lot number is unknown.The assembly process was reviewed.As the batch number is unavailable, the probable cause of the gel on the cannula could be due to the accumulation of lubrication on the tubing surface which might drip to the cannula of the product.

• Brand Name: SYRINGE 3ML LL W/NDL ECLIPSE 25X1 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 11838891
• Report Number: 8041187-2021-00420
• Device Sequence Number: 3576074
• Product Code: FMI
• UDI-Device Identifier: 00382903057870
• UDI-Public: 00382903057870
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.10
• 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): 06/03/2021

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 Catalogue Number: 305787
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2021
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 05/17/2021
• Supplement Report FDA Received Date: 06/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1