MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE 50ML LL

Catalog Number 300865

Device Problem Free or Unrestricted Flow (2945)

Patient Problems Air Embolism (1697); Coma (2417)

Event Date 05/19/2021

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that syringe 50ml ll had air in the line.The following information was provided by the initial reporter: cerebral gas embolism related to a defective syringe that allowed air to enter the central venous catheter.It was during a report one month later for a propofol syringe found with air that we understood the cause of the embolism.Clinical consequences and current status of the patient or person involved: abrupt coma secondary to gas embolism ct scan shows distal pneumo-encephaly in favor of gas embolism.Tracheotomy and prolongation of the stay in the medical intensive care unit severe neurological damage including tetraparesis and mixed aphasia.Discharged on (b)(6) to the geriatric ward.Actions taken for the patient vis-à-vis the dm: emergency hyperbaric oxygen therapy.Information for the family and the patient.For the 1st incident (nacl syringe), there was a gas embolism and the syringe is suspected but an investigation is underway on your side? the gas embolism was diagnosed on the scanner (presence of several air bubbles in the brain), the whole team is looking for the cause of this embolism.At the meeting, we retraced the events to try to understand, but the only malfunction found was the syringe with air found when preparing the patient for transfer to the hyperbaric chamber.To date, the patient has motor sequelae due to cerebral ischemia caused by the gas embolism (+ prolonged stay).

Manufacturer Narrative

H6: investigation summary: several photos and two used samples were provided to our quality team for investigation.Upon visual inspection of the photos and returned product, air bubbles within the fluid contained in the syringe were observed.The syringes returned were emptied, cleaned, and filled with water, no air bubbles or other abnormalities were seen within the syringe.The product was further evaluated, there was no damage or molding defects identified on the product.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.As the lot involved in this incident is unknown, a complaint history review cannot be performed.No changes have been made in the material or manufacturing process for this product.Based on the available information we are not able to determine a root cause related to the product or our manufacturing process at this time.Complaints received for this defect and device will be monitored by our quality team for signs of emerging trends.H3 other text : see h10.

Event Description

It was reported that syringe 50ml ll had air in the line.The following information was provided by the initial reporter: cerebral gas embolism related to a defective syringe that allowed air to enter the central venous catheter.It was during a report one month later for a propofol syringe found with air that we understood the cause of the embolism.Clinical consequences and current status of the patient or person involved: abrupt coma secondary to gas embolism ct scan shows distal pneumo-encephaly in favor of gas embolism.Tracheotomy and prolongation of the stay in the medical intensive care unit severe neurological damage including tetraparesis and mixed aphasia.Discharged on (b)(6) 2021 to the geriatric ward.Actions taken for the patient vis-à-vis the dm: emergency hyperbaric oxygen therapy.Information for the family and the patient.- for the 1st incident (nacl syringe), there was a gas embolism and the syringe is suspected but an investigation is underway on your side? the gas embolism was diagnosed on the scanner (presence of several air bubbles in the brain), the whole team is looking for the cause of this embolism.At the meeting, we retraced the events to try to understand, but the only malfunction found was the syringe with air found when preparing the patient for transfer to the hyperbaric chamber.To date, the patient has motor sequelae due to cerebral ischemia caused by the gas embolism (+ prolonged stay).

Event Description

It was reported that syringe 50ml ll had air in the line.The following information was provided by the initial reporter: cerebral gas embolism related to a defective syringe that allowed air to enter the central venous catheter.It was during a report one month later for a propofol syringe found with air that we understood the cause of the embolism.Clinical consequences and current status of the patient or person involved: abrupt coma secondary to gas embolism ct scan shows distal pneumo-encephaly in favor of gas embolism.Tracheotomy and prolongation of the stay in the medical intensive care unit severe neurological damage including tetraparesis and mixed aphasia.Discharged on june 29 to the geriatric ward.Actions taken for the patient vis-à-vis the dm: emergency hyperbaric oxygen therapy.Information for the family and the patient.For the 1st incident (nacl syringe), there was a gas embolism and the syringe is suspected but an investigation is underway on your side? the gas embolism was diagnosed on the scanner (presence of several air bubbles in the brain), the whole team is looking for the cause of this embolism.At the meeting, we retraced the events to try to understand, but the only malfunction found was the syringe with air found when preparing the patient for transfer to the hyperbaric chamber.To date, the patient has motor sequelae due to cerebral ischemia caused by the gas embolism (+ prolonged stay).

Manufacturer Narrative

Correction: h5: imdrf annex c grid: c070601 - deformation problem.H5: imdrf annex d grid: d15 - cause not established h3: see h10.

• Brand Name: SYRINGE 50ML LL
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12186140
• MDR Text Key: 264847820
• Report Number: 3003152976-2021-00400
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300865
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2022
• 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