MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD 50 ML SYRINGE

Catalog Number UNKNOWN

Device Problems Break (1069); Leak/Splash (1354)

Patient Problems High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Underdose (2542)

Event Date 10/07/2020

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: (b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.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.(b)(4).

Event Description

It was reported that an unspecified number of an unspecified bd 50 ml syringe experienced device damage/deformation while still considered operable and a failure to contain blood/medication during use.The following information was provided by the initial reporter: i have been sent details of an incident involving a bd 50ml syringe.The user reported that the patient was on noradrenaline 12mg running at 5ml/hour via pump and suddenly patient become very hypertensive ,so noradrenaline stopped and icu doctor informed.Reviewed by doctor and as per order labetolol infusion started ,few minutes later patient become hypotensive, so restarted noradrenaline 12mg and rate increased to maintain map above 65mmhg and noradrenaline was not responding and patient went in to peri arrest so adrenaline boluses given and adrenaline infusion started.Fluid boluses and albumin given.Abg ,chest x ray ,ecg done and reviewed and decided by doctors to change to a different lumen in cvc line.While changing noradrenaline syringe to a different lumen in cvc spotted dripping from noradrenaline pump and big crack in the syringe by nurse in charge,icu consultants were present at bedside throughout the episodes.Stand by noradrenaline syringe commenced on different lumen in cvc line and blood pressure became stable and patient settled.Informed shift leader , medical team and nursing team at bed side.Syringe pump and broken syringe handed over to shift leaders office for further investigation.Our engineers have checked the pump device with no faults noted but it has been kept in quarantine for the time being along with the syringe.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for evaluation? yes.D10: returned to manufacturer on:(b)(6) 2020.H6: investigation summary a device history record review was not performed as the lot is unknown.To aid in the investigation of this incident, 1 physical sample and 3 picture samples were received for evaluation by our quality team.The physical sample came in a plastic bag and a visual inspection was performed.This is 50ml syringe ll type, it has a label adhered to it and the barrel has a crack that is about 2.5¿ long.It goes from about the 37ml and goes down to the bottom of the barrel.The 3 photos were provided show the sample received.The cause for this defect could have resulted during the assembly process where a jam could have occurred where the plunger rod-rubber stopper is assembled to the barrel, inducing the crack.Further action has not been determined necessary at this time.Our quality team will continue to monitor the manufacturing process for this defect and other emerging trends.

Event Description

It was reported that an unspecified number of an unspecified bd 50 ml syringe experienced device damage/deformation while still considered operable and a failure to contain blood/medication during use.The following information was provided by the initial reporter: i have been sent details of an incident involving a bd 50ml syringe.The user reported that the patient was on noradrenaline 12mg running at 5ml/hour via pump and suddenly patient become very hypertensive ,so noradrenaline stopped and icu doctor informed.Reviewed by doctor and as per order labetolol infusion started ,few minutes later patient become hypotesive, so restarted noradrenaline 12mg and rate increased to maintain map above 65mmhg and noradrenaline was not responding and patient went in to peri arrest so adrenaline boluses given and adrenaline infusion started.Fluid boluses and albumin given.Abg ,chest x ray ,ecg done and reviewed and decided by doctors to change to a different lumen in cvc line.While changing noradrenaline syringe to a different lumen in cvc spotted dripping from noradrenaline pump and big crack in the syringe by nurse in charge,icu consultants were present at bedside throughout the episodes.Stand by noradrenaline syringe commenced on different lumen in cvc line and blood pressure became stable and patient settled.Informed shift leader , medical team and nursing team at bed side.Syringe pump and broken syringe handed over to shift leaders office for further investigation.Our engineers have checked the pump device with no faults noted but it has been kept in quarantine for the time being along with the syringe.

• Brand Name: UNSPECIFIED BD 50 ML SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10752103
• MDR Text Key: 215365140
• Report Number: 2243072-2020-01755
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Date Manufacturer Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1