MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SYRINGE

Catalog Number UNKNOWN

Device Problem Leak/Splash (1354)

Patient Problem Chemical Exposure (2570)

Event Date 05/06/2020

Event Type  malfunction  

Manufacturer Narrative

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.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: 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.  the lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Investigation conclusion: part number and lot number is unknown; a lot history review could not be performed.Root cause description: no root cause can be determined as no samples were received.Rationale: capa is not required at this time.

Event Description

It was reported that the n35 detached from the unspecified bd¿ syringe during use while mixing "paclitaxel", and chemotherapy medication "shot everywhere" as a result.This occurred on 2 separate occasions, but the dates and/or patient information are unknown.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "we've now have had two instances in which the n35 has detached itself from the syringe during chemo mixing in the hood, shooting drug everywhere and causing a delay in patient care." "did both detachments occur on 05/06? no.Are you able to obtain the lot number(s) of the affected injectors? no.We prime our bags in the non-hazardous room and the trash is removed frequently, so it is impossible to know which lot was involved.Were the syringes bd syringes? yes.What was done to remedy the issue (i.E.Changed injector, switched entire system, etc.)? we had to decontaminate the entire hazardous cleaning hood, change garb, and remake the entire dose for the patient.We shut down all iv compounding for 15-20 mins after the spill.The spill was such that it would have been unsafe to send out any part of it and part of the dose was in the bag, so remixing from scratch in a different hood was the only safe solution.Do you believe that the issue could have been with the syringes? i am not sure how the syringes could have played in to this.Both instances have involved paclitaxel, which is viscous and often large volume (50+ml).We are not sure if the n35 became loose in transferring the medication from the syringe to the bag or if there was an issue with the syringe itself.".

• Brand Name: UNSPECIFIED BD SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 10080640
• MDR Text Key: 199867021
• Report Number: 2243072-2020-00805
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other