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

Catalog Number 300865

Device Problem Fluid/Blood Leak (1250)

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

Event Date 07/23/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that syringe 50ml ll leaked.The following information was provided by the initial reporter: the syringe is not contaminated with blood, but propofol.

Event Description

It was reported that syringe 50ml ll leaked.The following information was provided by the initial reporter: the syringe is not contaminated with blood, but propofol.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-08-16.H6: investigation summary : one sample received for investigation, a 50ll syringe with reference 300865 from lot 2104096.The syringe came with its original blister, opened and used.A device history review was performed for reported lot 2104096, no deviations or non-conformances related to this issue were identified during the manufacturing process.Upon visual inspection of the sample it can be observed the syringe has been used with a white high density liquid.This white substance has leaked past the stopper remaining between the ribs of the device, confirming one of the defects claimed by customer (leakage past the stopper).Stopper is correctly assembled, but damage in the barrel has been noticed.A damage in the barrel can deform the part causing a wrong interference between stopper and barrel that may lead to leakage.Functional testing was performed and no leaks were observed.The second defect noticed by customer is the emergence of air bubbles while aspirating the medicine into the syringe.Syringe was emptied, cleaned and filled with water again not showing abnormal air inside.Bubbles observed might be caused by drug density.Based on the available information we are not able to determine a root cause at this time, although damage in the barrel could contribute to the defect for leakage past the stopper.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.H3 other text : 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
• MDR Report Key: 12351696
• MDR Text Key: 267716783
• Report Number: 3003152976-2021-00497
• 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: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300865
• Device Lot Number: 2104096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Date Manufacturer Received: 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1