MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 0.5ML 31G 6MM S/C U-100 RELION; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	328520
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	03/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.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 a syringe 0.5ml 31g 6mm s/c u-100 relion had foreign matter before use.The following was reported by the initial reporter: it was reported clear oily substance" on her needle tip when she pushed on plunger verbatim: pet owner reported seeing "clear oily substance" on her needle tip when she pushed on plunger prior to injection stated, did not use the syringes she found with that "substance".
Additional Manufacturer Narrative
Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Due to the batch being unknown, no dhr review can be completed.
Event or Problem Description
It was reported that a syringe 0.5ml 31g 6mm s/c u-100 relion had foreign matter before use.The following was reported by the initial reporter: "it was reported clear oily substance" on her needle tip when she pushed on plunger verbatim: pet owner reported seeing "clear oily substance" on her needle tip when she pushed on plunger prior to injection stated, did not use the syringes she found with that "substance".".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes; d.10.Returned to manufacturer on: 4/30/2021.H.6.Investigation: customer returned (2) loose 3/10cc, 6mm syringes.Customer states that there was a clear oily substance on her needle tip when she pushed on the plunger.Both returned syringes were tested and one syringe exhibited a clear drop of liquid coming out the cannula when the plunger rod was fully depressed.A small portion of this material was removed from the sample and prepared for ftir spectral analysis.The spectral analysis shows that this material is most likely silicone.Unable to perform dhr check for foreign matter on needle tip due to unknown lot number.Root cause for this defect cannot be determined.
Event or Problem Description
It was reported that a syringe 0.5ml 31g 6mm s/c u-100 relion had foreign matter before use.The following was reported by the initial reporter: "it was reported clear oily substance" on her needle tip when she pushed on plunger.Pet owner reported seeing "clear oily substance" on her needle tip when she pushed on plunger prior to injection stated, did not use the syringes she found with that "substance".".

• Brand Name: SYRINGE 0.5ML 31G 6MM S/C U-100 RELION
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11720805
• Report Number: 2243072-2021-01250
• Device Sequence Number: 14559765
• Product Code: FMI
• UDI-Device Identifier: 00681131138369
• UDI-Public: 00681131138369
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K024112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2021

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: Lay User/Patient
• Device Model Number: 328520
• Device Catalogue Number: 328520
• 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: 03/29/2021
• Supplement Date Received by Manufacturer: 05/10/2021; 05/28/2021
• Initial Report FDA Received Date: 04/23/2021
• Supplement Report FDA Received Date: 05/21/2021; 06/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1