MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SYRINGE

Catalog Number UNKNOWN

Device Problem Leak/Splash (1354)

Patient Problems Emotional Changes (1831); Underdose (2542)

Event Date 04/16/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter date of birth: only the patient's age was given therefore a default date of birth has been listed.Device expiration date: unknown.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 the unspecified bd syringe experienced leakage at the connection site during use.The following information was provided by the initial reporter: material no: unknown batch no: unknown.Event description: upon first assessment, pt's dexmedetomidine line appeared to be leaking where the line connects to the syringe.Upon further inspection, there was a moderate sized puddle next to the bed which was clearly dexmedetomidine and the patient was reported to have been very uncomfortable all night and was visibly agitated upon first assessment.Appears that pt did not receive full dose of medication for several hours.Line was tightly connected to syringe but still leaking.Syringe and line replaced and saved.Pt resting comfortably at the time of this note.

Event Description

It was reported that the unspecified bd syringe experienced leakage at the connection site during use.The following information was provided by the initial reporter: material no: unknown batch no: unknown.Event description: upon first assessment, pt's dexmedetomidine line appeared to be leaking where the line connects to the syringe.Upon further inspection, there was a moderate sized puddle next to the bed which was clearly dexmedetomidine and the patient was reported to have been very uncomfortable all night and was visibly agitated upon first assessment.Appears that pt did not receive full dose of medication for several hours.Line was tightly connected to syringe but still leaking.Syringe and line replaced and saved.Pt resting comfortably at the time of this note.

Manufacturer Narrative

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.

• Brand Name: UNSPECIFIED BD SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10196814
• MDR Text Key: 198743011
• Report Number: 2243072-2020-00965
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• 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
• Date Manufacturer Received: 06/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 3 YR