MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD LUER-LOCK¿ SYRINGE; PISTON SYRINGE

Catalog Number 302113

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Bacterial Infection (1735)

Event Date 01/24/2023

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 black foreign matter was on the tip of the bd luer-lock¿ syringe barrel, but not noticed prior to injecting medicine, resulting in the patient becoming ill for 48+ hours.No further information detailing any type of medical intervention was provided.The following information was provided by the initial reporter: "notified by anonymous emailer that the end user noticed black type substance in tip of the barrel on the 3mm syringe barrel and proceeded to inject their medication.Resulting in end user becoming ill for 48+ hours.Good obtained from needle exchange program in and contact says that the package was sealed in new condition upon receiving the syringe.At the very tip of the barrel with the fluid would be excreted was a black type substance which resembled a type of grease this resulted in the user becoming very sick what is often called in the world of entering his drug use a dirty taste.This individual is extremely hygienic to a point where it's almost a 99.9% steroid environment but what is concerning is this particular product is in our doctor's offices our sexual health clinics and our hospitals.So i'm just wanting this folder to the, because whatever this my new substance is and was on the end of this three mil syringe barrel caused an extreme sickness reaction when the selected fluid was injected to the bloodstream.Again i can tell you that the packaging was completely sealed and went opened it's always handled from the plunger end and in no way did it contact or coming to contact with any foreign material it came into contact directly with the liquid which was not present with any debris or staining black material the substance that was drawn up into the plastic three more barrel was pink or red and color there was nothing black or greased like in the stereo container that it was held in this is very alarming and it needs addressing.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 13-feb-2023.H6: investigation summary our quality engineer inspected the 1 photo and 2 samples submitted for evaluation.The reported issues of foreign matter and infection were confirmed upon inspection and testing of the samples.Analysis of the samples showed that there was foreign matter on each sample.Ftir testing was performed to identify the material of the foreign particulates, but the results came back inconclusive.Since we were unable to determine the makeup of the particles, we are unable to determine a root cause of the failure.Production records were reviewed and there was one instance of foreign matter within packaging during the production of this batch.H3 other text : see h10.

Event Description

It was reported that black foreign matter was on the tip of the bd luer-lock¿ syringe barrel, but not noticed prior to injecting medicine, resulting in the patient becoming ill for 48+ hours.No further information detailing any type of medical intervention was provided.The following information was provided by the initial reporter: "notified by anonymous emailer that the end user noticed black type substance in tip of the barrel on the 3mm syringe barrel and proceeded to inject their medication.Resulting in end user becoming ill for 48+ hours.Good obtained from needle exchange program in.And contact says that the package was sealed in new condition upon receiving the syringe.At the very tip of the barrel with the fluid would be excreted was a black type substance which resembled a type of grease this resulted in the user becoming very sick what is often called in the world of entering his drug use a dirty taste.This individual is extremely hygienic to a point where it's almost a 99.9% steroid environment but what is concerning is this particular product is in our doctor's offices our sexual health clinics and our hospitals.So i'm just wanting this folder to the.Because whatever this my new substance is and was on the end of this three mil syringe barrel caused an extreme sickness reaction when the selected fluid was injected to the bloodstream.Again i can tell you that the packaging was completely sealed and went opened it's always handled from the plunger end and in no way did it contact or coming to contact with any foreign material it came into contact directly with the liquid which was not present with any debris or staining black material the substance that was drawn up into the plastic three more barrel was pink or red and color there was nothing black or greased like in the stereo container that it was held in this is very alarming and it needs addressing.".

• Brand Name: BD LUER-LOCK¿ SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16375216
• MDR Text Key: 309528070
• Report Number: 8041187-2023-00057
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 302113
• Device Lot Number: 2074620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2022
• 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
• Patient Outcome(s): Other