MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 10 ML BD LUER-LOK SYRINGE WITH BD PRECISIONGLIDE NEEDLE; PISTON SYRINGE

Catalog Number	309644
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.Device manufacture date: unknown.Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that scale marking issue were found during use with a 10 ml bd luer-lok¿ syringe with bd precisionglide¿ needle.The following information was provided by the initial reporter."glue piston - doubts about the reliability of graduation - squeegee does not glue properly (surface is as a cireuse but it is intermitting handling not well decreased speed of drug administration nurse says that when it takes a medicine there is some quantity whereas it does not arrive before, is not until a non-identifier drug (tightening stick) resute to a gaspille of medicine / loss of time / risk of error ( i do not have the total quantities affected.
Additional Manufacturer Narrative
Investigation summary: 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 scale marking issue were found during use with a 10 ml bd luer-lok¿ syringe with bd precisionglide¿ needle.The following information was provided by the initial reporter,."glue piston - doubts about the reliability of graduation - squeegee does not glue properly (surface is as a cireuse but it is intermitting handling not well decreased speed of drug administration nurse says that when it takes a medicine there is some quantity whereas it does not arrive before, is not until a non-identifier drug (tightening stick) resute to a gaspille of medicine / loss of time / risk of error ( i do not have the total quantities affected.

• Brand Name: 10 ML BD LUER-LOK SYRINGE WITH BD PRECISIONGLIDE NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8744321
• Report Number: 1213809-2019-00678
• Device Sequence Number: 11262294
• Product Code: FMF
• UDI-Device Identifier: 30382903096443
• UDI-Public: 30382903096443
• 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: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2019

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: Health Professional
• Device Catalogue Number: 309644
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 06/07/2019
• Supplement Date Received by Manufacturer: 06/07/2019
• Initial Report FDA Received Date: 06/28/2019
• Supplement Report FDA Received Date: 07/12/2019
• 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