MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL W/NDL 20X1 RB; PISTON SYRINGE

Catalog Number	309578
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It has been reported that one syringe 3ml ll w/ndl 20x1 rb has been found containing foreign matter before use.The following has been provided by the initial reporter: it was reported that prior to injecting glycopyrrolate the nurse had trouble pushing the medicine trough and had to have the doctor on duty remove the syringe from the needle and that's when a foreign substance was noticed in the syringe.Per email: we, hopefully, averted what could have been a very serious, life-threatening situation this morning.Glycopyrrolate was drawn up into a bd 3 ml syringe, lot #9140817, item #309578.There was no difficulty in drawing up the medication; however, when the nurse attempted to give the medication, the needle could not be removed by the nurse.The medical director was in the bay, and he was able to remove the needle from the syringe.When he did so, he noted the foreign body in the syringe.We immediately pulled all syringes from this lot number and saved the medication vials from which the medication was drawn.The medication vials do not appear to have any contaminants in them.We have taken the contaminated syringe to our lab director.She will look at it under the microscope, and, if possible, culture a small part of the contaminant.
Additional Manufacturer Narrative
H.6.Investigation summary one photo and one thousand 3ml syringes in fully sealed blister packs from batch 9140813 (p/n 309678) were received and evaluated.It was observed in the photo and in one of the received samples there was brown foreign matter attached to the tip of the syringe in the fluid path.It appeared to be grease and was larger than level 2 in size which was rejectable per product specification.The machine was inspected on (b)(6) 2019 for all possible points of contact with the tip of the syringe.From the limited number of contact points, it was determined the contamination occurred during assembly.The sample was sent for ftir (fourier transform infrared) to confirm the composition of the foreign mater.Ftir analysis was completed on the dark material observed in the barrel tip.A small portion of this material was removed from the sample and prepared for ftir spectral analysis.The spectral analysis shows that this material is most likely grease mixed with polypropylene.Potential root cause for the foreign matter defect is associated with the assembly process.It is possible machine adjustments were made at assembly and excess grease was not removed properly.During the inspection on (b)(6) 2019, no contamination of syringes was observed.No corrective actions are necessary based on the defective rate identified.Batch 9140813 is considered in compliance with our product specification requirements.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.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.H3 other text : see section h.10.
Event or Problem Description
It has been reported that one syringe 3ml ll w/ndl 20x1 rb has been found containing foreign matter before use.The following has been provided by the initial reporter: it was reported that prior to injecting glycopyrrolate the nurse had trouble pushing the medicine trough and had to have the doctor on duty remove the syringe from the needle and that's when a foreign substance was noticed in the syringe.

• Brand Name: SYRINGE 3ML LL W/NDL 20X1 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9292846
• Report Number: 1213809-2019-01120
• Device Sequence Number: 11333463
• Product Code: FMF
• UDI-Device Identifier: 30382903095781
• UDI-Public: 30382903095781
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2020

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 Expiration Date: 04/30/2024
• Device Catalogue Number: 309578
• Device Lot Number: 9140817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Initial Date Received by Manufacturer: 10/23/2019
• Supplement Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 11/07/2019
• Supplement Report FDA Received Date: 01/15/2020
• 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