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

Catalog Number	309644
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/27/2019
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, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that during use of the 10 ml bd luer-lok¿ syringe with bd precisionglide¿ needle when mixing drug clinician discovered what looked to be a piece of the plunger hanging inside the syringe while mixing the drug.There were two occurrence.This complaint is capturing the foreign matter for the 10ml syringe's.Per description on incident form: 20ml syringe, item # 30283,0 lot: 8332972.This one has grease on the outside of the syringe.We also had a 10ml with grease down in where the needle screws in and it looks like a black fuzz and another 20ml that had grease inside the syringe where the barrel is.But we do not have the lot # foe them.
Additional Manufacturer Narrative
Investigation: one plastic bag containing a loose 3ml syringe with needle, a 10ml syringe and a 20ml syringe, along with opened packages from 3ml batch #8361518 (p/n 309578) and 10ml batch #8318927 (p/m 309644) were received.The samples were visually evaluated.The 10ml syringe had a small amount of black foreign matter on the edge of the luer collar in two spots.The foreign matter appeared to be grease.However, the syringe was loose in the same bag as the 20ml syringe, which was observed to have a large amount of grease on the outside of the barrel wall.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Since all of the samples were loose in the same bag and not in the original packaging potential it is difficult to determine a potential root cause for the small amount of grease on the 10ml syringe.Although it is possible to have originated during the manufacturing process, it is also possible it was due to contact with the 20ml syringe or another undetermined origin.The defect could not be confirmed to have originated at the manufacturing plant.
Event or Problem Description
It was reported that during use of the 10 ml bd luer-lok¿ syringe with bd precisionglide¿ needle when mixing drug clinician discovered what looked to be a piece of the plunger hanging inside the syringe while mixing the drug.There were two occurrence.This complaint is capturing the foreign matter for the 10ml syringe's.Per description on incident form: 20ml syringe, item # 302830, lot 8332972.This one has grease on the outside of the syringe.We also had a 10ml with grease down in where the needle screws in and it looks like a black fuzz¿¿ and another 20ml that had grease inside the syringe where the barrel is.But we do not have the lot # foe them.

• 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: 8433277
• Report Number: 1213809-2019-00362
• Device Sequence Number: 239267
• Product Code: FMF
• UDI-Device Identifier: 30382903096443
• UDI-Public: 30382903096443
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 05/06/2019

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: 309644
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2019
• Initial Date Received by Manufacturer: 02/28/2019
• Supplement Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 03/19/2019
• Supplement Report FDA Received Date: 05/06/2019
• 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