MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD PLASTIPAK¿ SYRINGE LUER-LOK¿; HYPODERMIC SYRINGE

Catalog Number	309661
Health Effect - Clinical Code	Vomiting (2144)
Date of Event	05/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Fda notified yes: the initial reporter also notified the fda on 05/09/2018 via medwatch # (b)(4).Investigation results: conclusion: 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.Examination of the product involved may provide clarification as to the cause for the reported failure.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.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.A device history review could not be completed as no batch number was provided.Root cause: root cause is undetermined.
Event or Problem Description
It was reported that leakage occurred while using a bd plastipak¿ syringe 20ml luer-lok¿ the clinical trial subject experienced a leakage of csf from the icv device.The subject experienced vomiting during the night and was visited by the neurological team several times.In addition, it was reported the subject remained in the hospital as a precaution.The outcome of the event was reported as recovered/resolved on (b)(6) 2018.

• Brand Name: BD PLASTIPAK¿ SYRINGE LUER-LOK¿
• Common Device Name: HYPODERMIC SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7571847
• Report Number: 1911916-2018-00260
• Device Sequence Number: 13511162
• Product Code: FMF
• UDI-Device Identifier: 30382903096610
• UDI-Public: 30382903096610
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,study,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/05/2018

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: Physician
• Device Catalogue Number: 309661
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2018
• Initial Report FDA Received Date: 06/05/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 3 YR
• Patient Weight: 12