MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL; PISTON SYRINGE

Catalog Number	309585
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.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.309585, batch no.Unknown.It was reported that during use of the syringe 3 ml ll there is syringe needle connectivity issue, syringes are leaking when used with covidien needles.The following information was provided by the initial reporter: this has happened several times with the a viscous medication however a non-viscous medication was used and i was able to recreate the leak with normal saline.The non-viscous medication is administered with the 3 ml syringe, however the viscous medication is administered from a 10 ml syringe.I believe there must be an issue with the 20g 5/8¿ needle fit in the threads of bd syringes, particularly if there is any resistance or viscosity to the medication.I do not have a number of times, as it was shared with me in passing by the nursing staff.I did find out it has occurred at both campuses over several months, thus making me believe it is not a specific lot.
Event or Problem Description
Material no.309585 batch no.Unknown.It was reported that during use of the syringe 3ml ll there is syringe needle connectivity issue, syringes are leaking when used with covidien needles.The following information was provided by the initial reporter: this has happened several times with the a viscous medication however a non-viscous medication was used and i was able to recreate the leak with normal saline.The non-viscous medication is administered with the 3ml syringe, however the viscous medication is administered from a 10ml syringe.I believe there must be an issue with the 20g 5/8¿ needle fit in the threads of bd syringes, particularly if there is any resistance or viscosity to the medication.I do not have a number of times, as it was shared with me in passing by the nursing staff.I did find out it has occurred at both campuses over several months, thus making me believe it is not a specific lot.
Additional Manufacturer Narrative
Investigation: four photos were received and evaluated.One photo displays a loose 3ml bd syringe with a magellan safety needle attached and the top webs of each of the products.Due to poor picture quality the batch and part number could not be determined.One photo displayed the syringe and needle assembly with 1.5ml of clear fluid with observable leakage at the connection point.One photo displays a red carton containing fully sealed 3ml syringes.One photo displays a red carton containing fully sealed safety needles it is unclear from the photos what is causing the leakage.A physical unused syringe in addition to an unused safety needle are needed for a more thorough evaluation.A device history record review could not be performed as lot number was unknown.

• Brand Name: SYRINGE 3ML LL
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8970588
• Report Number: 1213809-2019-00902
• Device Sequence Number: 19554103
• Product Code: FMF
• UDI-Device Identifier: 30382903095859
• UDI-Public: 30382903095859
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2019

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: Other
• Device Catalogue Number: 309585
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 08/19/2019
• Supplement Date Received by Manufacturer: 08/19/2019
• Initial Report FDA Received Date: 09/06/2019
• Supplement Report FDA Received Date: 10/16/2019
• 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