MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL W/BLUNT PLASTIC CANN; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	303346
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 9239116 medical device expiration date: 2024-07-31 device manufacture date: (b)(6) 2019.Medical device lot #: 9239129 medical device expiration date: 2024-07-31 device manufacture date: (b)(6) 2019.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that syringe 3ml ll w/blunt plastic can had foreign matter.The following information was provided by the initial reporter: material no: 303346, batch no: 9239116 and 9239129.It was reported the cannula is dull and when you apply pressure it actually cores the stopper on the vial and pushes plastic into the medicine.Verbatim: we noticed the issue on (b)(6) 2021.I have the label and will send the product.I will bag each lot number separately.Injuries or adverse event: no.Are any samples available for return? yes.Reported issue: the cannula is dull and when you apply pressure it actually cores the stopper on the vial and pushes plastic into the medicine.We tried a few syringes and they are all doing the same thing.This is a huge safety concern so i need to pull all the product i have on hand.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 2/5/2021.H.6.Investigation: one plastic bag of approximately one hundred 3ml syringes in fully sealed blister packs from batch 9239116 (p/n 303346) were received and evaluated.No cannula defects were observed.The reported defect was not identified in the samples received.No defects were confirmed with the returned product.Based on the verbatim, it is possible the product was not used with the appropriate septum.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 syringe 3ml ll w/blunt plastic cann had foreign matter.The following information was provided by the initial reporter: material no: 303346 batch no: 9239116 and 9239129.It was reported the cannula is dull and when you apply pressure it actually cores the stopper on the vial and pushes plastic into the medicine.Verbatim: we noticed the issue on (b)(6) 2021.I have the label and will send the product.I will bag each lot number separately.Injuries or adverse event: no.Are any samples available for return? yes.Reported issue: the cannula is dull and when you apply pressure it actually cores the stopper on the vial and pushes plastic into the medicine.We tried a few syringes and they are all doing the same thing.This is a huge safety concern so i need to pull all the product i have on hand.

• Brand Name: SYRINGE 3ML LL W/BLUNT PLASTIC CANN
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 11306917
• Report Number: 1213809-2021-00066
• Device Sequence Number: 11606522
• Product Code: FMI
• UDI-Device Identifier: 30382903033462
• UDI-Public: 30382903033462
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K974363
• 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): 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 303346
• Device Catalogue Number: 303346
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Initial Date Received by Manufacturer: 01/14/2021
• Supplement Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 02/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1