MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE S2 10ML; SYRINGE, PISTON

Catalog Number 309110

Device Problem Fluid/Blood Leak (1250)

Patient Problem Low Oxygen Saturation (2477)

Event Date 10/29/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4): initial mdr submission.A follow up mdr will be submitted if a device evaluation and/or device history review is completed.Patient problem code: f1004 - underdose e2203 - low oxygen saturation device problem code: a050401 - fluid/blood leak.

Event Description

Rapid sequence induction in the emergency operating room for a patient with appendicitis.The anesthetist injects the first syringe of propofol 2% and informs me of leaks.The second syringe of propofol 2% is injected without any problem.After intubation, there are difficulties with ventilation and moderate desaturation due to a defect in the depth of anesthesia.The anesthesiologist takes one of the empty propofol syringes to fill it and reinject it.During this new injection there are again leaks at the piston level.Injection is faster and leaks are (there are plenty of them on the doctor's hand).The patient ends up being ventilated, the saturation rises.Patient's current condition: amount of propofol administered is less than intended.Anesthesia less deep than desaturation, rapid reinjection of propofol.There is a risk to the patient, particularly in emergency situations situations where deep anesthesia is the treatment of choice.Actions taken in the care facility to manage the patient: nr we don't have it, as we've only recovered the syringe on which the batch number does not appear.1 other syringe is already being examined by you yes, the syringe is available used (during use)-contains propofol.

Manufacturer Narrative

To aid in the investigation of this issue, one (1) sample syringe was returned for evaluation by our quality team.Through examination of the sample, the reported issue of leakage was identified.As a lot number was unknown for this incident, a device history record review could not be performed.It has been determined that the observed leakage resulted from damage to the plunger component.Although the exact manufacturing cause could not be determined, this type of damage may occur during the handling of the product through the manufacturing process or within the plunger assembly machine.Based on the preventive measures in place, we believe this was an isolated incident with an unlikely chance of recurrence.At this time, further action has not been determined necessary.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.

Event Description

No additional information.

• Brand Name: SYRINGE S2 10ML
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca IL 22520 ; SP 22520
• Manufacturer Contact: helen cox ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18275193
• MDR Text Key: 329841732
• Report Number: 3002682307-2023-00349
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903091102
• UDI-Public: (01)00382903091102
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 309110
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention