MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD ¿ SYRINGE; PISTON SYRINGE

Catalog Number UNKNOWN

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 07/21/2023

Event Type  Injury  

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 franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that while using the unspecified bd ¿ syringe there was a crack and medication was leaking.The following was received from the initial reporter: icu patient dropped their blood pressure spontaneously.Upon checking found fluid dripping from the infusion pump which was coming from noradrenaline 16 mg syringe.The syringe was found to have a big crack on it which probably caused the medications not to infuse as set on the syringe pump.These syringes are pre-filled for by another neighbouring nhs trust.They come with an expiry date with regards the drug but it seems there is an additional consideration when the bd plasti-pak is stored in a fridge for a prolonged period of time, the syringe can become more brittle and prone to impact damage.This syringe was prepared in april and so had been in a fridge for over two months.

Event Description

It was reported that while using the unspecified bd ¿ syringe there was a crack and medication was leaking.The following was received from the initial reporter: icu patient dropped their blood pressure spontaneously.Upon checking found fluid dripping from the infusion pump which was coming from noradrenaline 16 mg syringe.The syringe was found to have a big crack on it which probably caused the medications not to infuse as set on the syringe pump.These syringes are pre-filled for by another neighbouring nhs trust.They come with an expiry date with regards the drug but it seems there is an additional consideration when the bd plasti-pak is stored in a fridge for a prolonged period of time, the syringe can become more brittle and prone to impact damage.This syringe was prepared in april and so had been in a fridge for over two months.

Manufacturer Narrative

The following fields have been updated due to additional information: device available for eval?: yes.Returned to manufacturer on: 19-oct-2023.Investigation summary: it was reported the syringe was found to have a big crack on it.To aid in the investigation, one sample with no packaging blister was received for evaluation by our quality team.A visual inspection was performed, and there is a vertical crack from the bottom of the syringe that is 3 1/2" long.There is a second horizontal barrel crack about 1 1/2" long located at the 15ml mark on the graduation scale.No other defects or imperfections were observed.It could be possible the customer is not using the product as intended.These syringes are not designed to store medications or be frozen.As the material and lot number provided are 'unknown,' a device history record review could not be completed.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.However, the way the syringe had been used may have caused the plastic to become brittle.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: UNSPECIFIED BD ¿ SYRINGE
• Type of Device: PISTON 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17507402
• MDR Text Key: 320853382
• Report Number: 2243072-2023-01423
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention