MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL W/NDL SFTYGLD 25X1 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305924
Medical Device Problem Codes	Fungus in Device Environment (2316); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8064678.Medical device expiration date: 2023-02-28.Device manufacture date: 2018-03-05.Medical device lot #: 8119703.Medical device expiration date: 2023-04-30.Device manufacture date: 2018-04-29.(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that syringe 3ml ll w/ndl sftygld 25x1 rb had mold located on the needle hub.This was discovered before use.The following information was provided by the initial reporter: material no.: 305924, batch no.: 8064678 & 8119703.It was reported there appeared to be mold located in the needle hub.Verbatim: nurse went to open bd safetyglide(3ml 25g x 1) lot # 8064678.Located in the needle hub was which appears to be mold.
Additional Manufacturer Narrative
H.6.Investigation summary one safetyglide syringe needle combo in an opened package from batch #8064678 (p/n 305924) and one safetyglide syringe needle combo in a sealed package from batch #8119703 (p/n 305924), were received.The samples were visually evaluated.The needle in the opened package was observed to have loose black foreign matter particles on the inside surface of the needle hub in and outside the fluid path.The sample in the sealed package was observed through the package without being opened to not affect sterility for microbiological testing to follow.No foreign matter was observed in the sample through the package.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Fourier transform infrared spectroscopy (ftir) analysis was completed on the material observed on the inner surface of the needle hub.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 tygon (tubing that can be used in a wide range of applications including laboratory and surgical settings).Since no evidence of mold growth was observed on either sda agar plate, mold contamination may be ruled out as a contaminant of the bd 3ml safetyglidetm 25g x 1 syringe lot#8119703, catalog # 305924 examined during this investigation.Potential root cause for the foreign matter defect could not be confirmed to have originated at the needle packaging plant at this time, no corrective actions are necessary based on the defective rate identified.Batch 8064678 is considered in compliance with our product specification requirements.No defects were confirmed with batch 8119703.The batch is in compliance with our product specification requirements.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see section h.10.
Event or Problem Description
It was reported that syringe 3ml ll w/ndl sftygld 25x1 rb had mold located on the needle hub.This was discovered before use.The following information was provided by the initial reporter: material no.: 305924 batch no.: 8064678 & 8119703.It was reported there appeared to be mold located in the needle hub.Verbatim: nurse went to open bd safetyglide(3ml 25g x 1) lot # 8064678.Located in the needle hub was which appears to be mold.

• Brand Name: SYRINGE 3ML LL W/NDL SFTYGLD 25X1 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9520348
• Report Number: 1213809-2019-01303
• Device Sequence Number: 14174113
• Product Code: FMI
• UDI-Device Identifier: 30382903059240
• UDI-Public: 30382903059240
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K951254
• 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): 03/17/2020

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 Model Number: 305924
• Device Catalogue Number: 305924
• Device Lot Number: SEE H.10
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 03/17/2020
• 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