MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL W/NDL 18X1-1/2 RB; PISTON SYRINGE

Model Number	309580
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that syringe 3ml ll w/ndl 18x1-1/2 rb had foreign matter inside the barrel of the syringe.This was discovered during use.The following information was provided by the initial reporter: material no.: 309580 batch no.: 0077232.It was reported that water was found inside the barrel of the syringe and also liquid was found in the sealed packaging.
Additional Manufacturer Narrative
H.6.Investigation: no photos or samples were received for evaluation.Based on the verbatim, it is possible the ¿liquid¿ was silicone.Please note that silicone is an inert, non-toxic medical substance used as a lubricant for disposable hypodermic products.It is an integral part of the syringe, enabling it to perform as required in various clinical applications and does not present a safety or efficacy issue nor does it impact product function.Since no samples displaying the reported condition were received a potential root cause could not be defined and no corrective actions are necessary at this time.Dhr was performed.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect h3 other text : see h.10.
Event or Problem Description
It was reported that syringe 3ml ll w/ndl 18x1-1/2 rb had foreign matter inside the barrel of the syringe.This was discovered during use.The following information was provided by the initial reporter: material no.: 309580 batch no.: 0077232 it was reported that water was found inside the barrel of the syringe and also liquid was found in the sealed packaging.

• Brand Name: SYRINGE 3ML LL W/NDL 18X1-1/2 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10141342
• Report Number: 1213809-2020-00385
• Device Sequence Number: 19374082
• Product Code: FMF
• UDI-Device Identifier: 30382903095804
• UDI-Public: 30382903095804
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (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): 06/16/2020

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: 02/28/2025
• Device Model Number: 309580
• Device Catalogue Number: 309580
• Device Lot Number: 0077232
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/21/2020
• Supplement Date Received by Manufacturer: 05/21/2020
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 06/17/2020
• 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