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

Model Number	309656
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of birth: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that blood "spurted" onto the patient during use after injecting them with the syringe 3ml ls 200 s/c.The following information was provided by the initial reporter: "after injecting a patient, blood spurted out on to the patient.There was no additional medical assistance required, the blood was cleaned up.".
Event or Problem Description
It was reported that blood "spurted" onto the patient during use after injecting them with the syringe 3ml ls 200 s/c.The following information was provided by the initial reporter: "after injecting a patient, blood spurted out on to the patient.There was no additional medical assistance required, the blood was cleaned up.".
Additional Manufacturer Narrative
H.6.Investigation: no photos or samples were received for evaluation.Dhr was performed.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 9002525 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Since no samples displaying the reported condition were received a potential root cause could not be defined and no corrective actions are required at this time.

• 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: 10269542
• Report Number: 1213809-2020-00460
• Device Sequence Number: 13714467
• Product Code: FMF
• UDI-Device Identifier: 30382903096566
• UDI-Public: 30382903096566
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2020

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: 12/31/2023
• Device Model Number: 309656
• Device Catalogue Number: 309656
• Device Lot Number: 9002525
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/23/2020
• Supplement Date Received by Manufacturer: 06/23/2020
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 07/24/2020
• 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
• Patient Age: 40 YR