MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LS 200 S/C; PISTON SYRINGE

Model Number	309656
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.(b)(4).
Event or Problem Description
It was reported that syringe 3ml ls 200 s/c leaked during use.The following information was provided by the initial reporter: material no.: 309656, batch no.: unknown.It was reported that the syringe would not fit the transfer device which caused leakage at the luer connection.Concern description: reported by user that the slip tip did not fit securely on the transfer device.Upon attaching transfer device to syringe and transferring blood to the vacutainers, specimen leaked out around the tip end.
Additional Manufacturer Narrative
H.6.Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.
Event or Problem Description
It was reported that syringe 3ml ls 200 s/c leaked during use.The following information was provided by the initial reporter: material no.: 309656 batch no.: unknown.It was reported that the syringe would not fit the transfer device which caused leakage at the luer connection.Concern description: reported by user that the slip tip did not fit securely on the transfer device.Upon attaching transfer device to syringe and transferring blood to the vacutainers, specimen leaked out around the tip end.

• Brand Name: SYRINGE 3ML LS 200 S/C
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10112558
• Report Number: 1213809-2020-00362
• Device Sequence Number: 2405529
• Product Code: FMF
• UDI-Device Identifier: 30382903096566
• UDI-Public: 30382903096566
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K980987
• 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): 06/10/2020

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 Model Number: 309656
• Device Catalogue Number: 309656
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/13/2020
• Supplement Date Received by Manufacturer: 05/13/2020
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 06/10/2020
• 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