MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL W/NDL 22X1-1/2 RB; PISTON SYRINGE

Catalog Number	309574
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	11/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 an unspecified number of syringe 3ml ll w/ndl 22x1-1/2 rb experienced foreign matter contamination which was noted during use.The following information was provided by the initial reporter: material no.: 309574 batch no.: 9008859.Verbatim: customer noticed a white, waxy liquid when using the syringe and was wondering if this was normal.Customer wants to know if it is ok to use the syringes or if they need to be returned.
Additional Manufacturer Narrative
H.6.Investigation: one photo of cannula with brown hub was received and evaluated.It was observed the was a white foreign matter attached to the cannula near the tip.It appeared to be epoxy used to secure the cannula to the hub and was rejectable per product specification.Potential root cause for the epoxy on needle defect is associated with the needle manufacturing process.The photo was evaluated at the needle manufacturing site for evaluation and potential root cause determination.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.H3 other text : see h.10.
Event or Problem Description
It was reported that an unspecified number of syringe 3ml ll w/ndl 22x1-1/2 rb experienced foreign matter contamination which was noted during use.The following information was provided by the initial reporter: material no.: 309574; batch no.: 9008859.Verbatim: customer noticed a white, waxy liquid when using the syringe and was wondering if this was normal.Customer wants to know if it is ok to use the syringes or if they need to be returned.

• Brand Name: SYRINGE 3ML LL W/NDL 22X1-1/2 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9355484
• Report Number: 1213809-2019-01165
• Device Sequence Number: 535238
• Product Code: FMF
• UDI-Device Identifier: 30382903095743
• UDI-Public: 30382903095743
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2020

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: Other
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 309574
• Device Lot Number: 9008859
• Initial Date Received by Manufacturer: 11/01/2019
• Supplement Date Received by Manufacturer: 11/01/2019
• Initial Report FDA Received Date: 11/21/2019
• 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