MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK; PISTON SYRINGE

Catalog Number	309634
Medical Device Problem Codes	Volume Accuracy Problem (1675); Device Contamination with Chemical or Other Material (2944)
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
Medical device expiration date: unknown.Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
Material no: 309634, batch no: unknown.It was reported that during use of the bd¿ luer-lok syringe the graduation marks do not stick well and there is foreign matter on the surface of barrel a waxy substance.The number of occurrences along with the date/time and or patient information is unknown.Foreign complaint the following information was provided by the initial reporter: details of complaint (reported issue): 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
Usage of device: initial.
Event or Problem Description
Material no: 309634, batch no: unknown.It was reported that during use of the bd¿ luer-lok syringe the graduation marks do not stick well and there is foreign matter on the surface of barrel a waxy substance.The number of occurrences along with the date/time and or patient information is unknown.Foreign complaint the following information was provided by the initial reporter, translated from french to english: details of complaint (reported issue): 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).
Event or Problem Description
Material no: 309634 batch no: unknown it was reported that during use of the bd¿ luer-lok syringe the graduation marks do not stick well and there is foreign matter on the surface of barrel a waxy substance.The number of occurrences along with the date/time and or patient information is unknown.Foreign complaint the following information was provided by the initial reporter, translated from french to english: details of complaint (reported issue): 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.A device history record review could not be performed as lot number was unknown.

• Brand Name: BD LUER-LOK
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8736362
• Report Number: 1213809-2019-00665
• Device Sequence Number: 1341811
• Product Code: FMF
• UDI-Device Identifier: 30382903096344
• UDI-Public: 30382903096344
• 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,Followup
• Report Date (Section B): 07/12/2019

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: 309634
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 06/07/2019
• Supplement Date Received by Manufacturer: 06/07/2019; 06/07/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 06/27/2019; 07/15/2019
• 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