MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD SYRINGE SAFETY 3ML LL 24X3/4 AN; PISTON SYRINGE

Catalog Number 300869

Device Problems Leak/Splash (1354); Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/30/2023

Event Type  malfunction  

Manufacturer Narrative

Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d.4.Medical device lot #: 2205101.D.4.Medical device expiration date: 30-apr-2027.H.4.Device manufacture date: 16-may-2022.D.4.Medical device lot #: 2207101.D.4.Medical device expiration date: 30-jun-2027.H.4.Device manufacture date: 14-jul-2022.D.4.Medical device lot #: 2106104.D.4.Medical device expiration date: 31-may-2026.H.4.Device manufacture date: 07-jun-2021.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 the bd syringe safety 3ml ll 24x3/4 an was damaged.The substance that has been used is smof lipid 20% the leakage starts after a while(few minutes) from starting solution.The solution produced in compounding company and send to the nicu in the hospital.The extension connected in the he hospital and manufactured by kdl.They had few events, part of them the syringe lure seems to be broken and in some cases the extension female lure was broken.

Event Description

It was reported that the bd syringe safety 3ml ll 24x3/4 an was damaged.The substance that has been used is smof lipid 20%.The leakage starts after a while (few minutes) from starting solution.The solution produced in compounding company and send to the nicu in the hospital.The extension connected in the he hospital and manufactured by kdl.They had few events, part of them the syringe lure seems to be broken and in some cases the extension female lure was broken.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 05-jul-2023.H6: investigation summary one sample, photos, and video received by our quality team for investigation.Upon visual inspection of the pictures and video received it can be observed the mating component attached to the syringe do not fits properly leading to leakage during use.Upon visual evaluation of the syringe, no defects or issue observed on the tip of the sample, therefore the incident is not confirmed.A device history review was performed for the reported lots 2207101, 2205101 and 2106104, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this incident.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.Based on the available information we are not able to identify a definitive root cause at this time.

• Brand Name: BD SYRINGE SAFETY 3ML LL 24X3/4 AN
• Type of Device: PISTON 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17002569
• MDR Text Key: 315934199
• Report Number: 3003152976-2023-00201
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300869
• Device Lot Number: 2106104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/30/2023
• Initial Date FDA Received: 05/25/2023
• Supplement Dates Manufacturer Received: 06/30/2023
• Supplement Dates FDA Received: 07/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2022
• 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