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

Catalog Number 309578

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Unspecified Infection (1930)

Event Date 12/23/2019

Event Type  Injury  

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 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.

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 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
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9587726
• MDR Text Key: 188339565
• Report Number: 2243072-2020-00029
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903095780
• UDI-Public: 00382903095780
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Other
• Device Catalogue Number: 309578
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 12/23/2019
• Initial Date FDA Received: 01/14/2020
• Supplement Dates Manufacturer Received: 12/23/2019
• Supplement Dates FDA Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other