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

Catalog Number	309578
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device expiration date: unknown.Date of event: unknown.The date received by manufacturer has been used for this field.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.Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.
Event or Problem Description
It was reported that an unspecified number of syringe 3ml ll w/ndl 20x1 rb were involved in serious injuries in the form of medical consultation resulting from a potential breach in sterility which was noted after use.It has been stated that multiple devices were used by the medical device operator after a potential sterility breach in the device packaging, resulting in "infection each time." this has resulted in a review of the user facility's procedures, and an unspecified number of the patient's receipt of additional medical consultation/treatment.The results of this additional medical consultation/treatment have not been specified.The following information was provided by the initial reporter: material no: 309578 batch no: unknown.Event description: distributor has a customer that uses the 3ml syringe/needle 309578.He wants to know if the syringes are still sterile once the box is opened.He uses one every few days to administer a medication and reports getting an infection each time.Response with additional information: informed that the needle and inside of the syringe will remain sterile until used or until the cap is removed.Recommended he contact his nurse or physician and review the medication process using the syringe to ensure he is doing it properly.Informed caller that this information would be sent as a complaint during the daily case upload.Caller unable to provide any patient information.
Additional Manufacturer Narrative
H.6.Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A device history record review could not be performed as lot number was unknown.
Event or Problem Description
It was reported that an unspecified number of syringe 3ml ll w/ndl 20x1 rb were involved in serious injuries in the form of medical consultation resulting from a potential breach in sterility which was noted after use.It has been stated that multiple devices were used by the medical device operator after a potential sterility breach in the device packaging, resulting in "infection each time." this has resulted in a review of the user facility's procedures, and an unspecified number of the patient's receipt of additional medical consultation/treatment.The results of this additional medical consultation/treatment have not been specified.The following information was provided by the initial reporter: material no: 309578 batch no: unknown.Event description: distributor has a customer that uses the 3ml syringe/needle 309578.He wants to know if the syringes are still sterile once the box is opened.He uses one every few days to administer a medication and reports getting an infection each time.Response with additional information: informed that the needle and inside of the syringe will remain sterile until used or until the cap is removed.Recommended he contact his nurse or physician and review the medication process using the syringe to ensure he is doing it properly.Informed caller that this information would be sent as a complaint during the daily case upload.Caller unable to provide any patient information.

• Brand Name: SYRINGE 3ML LL W/NDL 20X1 RB
• Common Device Name: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9587726
• Report Number: 2243072-2020-00029
• Device Sequence Number: 14353370
• Product Code: FMF
• UDI-Device Identifier: 00382903095780
• UDI-Public: 00382903095780
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 02/03/2020

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 Catalogue Number: 309578
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 12/23/2019
• Supplement Date Received by Manufacturer: 12/23/2019
• Initial Report FDA Received Date: 01/14/2020
• Supplement Report FDA Received Date: 02/03/2020
• 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