MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK SYRINGE STERILE, SINGLE USE; PISTON SYRINGE

Model Number 309646

Device Problem Fungus in Device Environment (2316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/15/2020

Event Type  malfunction  

Manufacturer Narrative

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 mold was found in the bd luer-lok¿ syringe sterile, single use before use.This occurred on 10 separate occasions, but the dates are unknown.The following information was provided by the initial reporter: "i was notified this afternoon that we have some syringes in our stock and on the floor that are contaminated/appear to have mold inside of the packaging.Nurses went through items on the floor and found some that appear contaminated to various degrees.More were found in our par bar bin.All the ones that have been found have the same lot # 9242988, exp date of 07/31/2024." "i know one of our staff members had a near miss with it and had medication drawn into syringe and moved toward i.V.To get ready to administer medication before it was noticed.".

Event Description

It was reported that black mold was found in the bd luer-lok¿ syringe sterile, single use and sterile pouch before use.This occurred on 10 separate occasions, but the dates are unknown.Medwatch report# (b)(4) was filed in response to this event.The following information was provided by the initial reporter: "i was notified this afternoon that we have some syringes in our stock and on the floor that are contaminated/appear to have mold inside of the packaging.Nurses went through items on the floor and found some that appear contaminated to various degrees.More were found in our par bar bin.All the ones that have been found have the same lot # 9242988, exp date of 07/31/2024." "i know one of our staff members had a near miss with it and had medication drawn into syringe and moved toward i.V.To get ready to administer medication before it was noticed." "medwatch report: a black colored substance, suspected as mold was found on a syringe before drawing up the medication.After further review of additional syringes, some were noticed with black speckles of similar substance inside the sterile pouch.".

Manufacturer Narrative

Correction: the customer provided a medwatch report.The following fields have been updated: b.5.Describe event or problem: it was reported that black mold was found in the bd luer-lok¿ syringe sterile, single use and sterile pouch before use.This occurred on 10 separate occasions, but the dates are unknown.Medwatch report# (b)(4) was filed in response to this event.The following information was provided by the initial reporter: "i was notified this afternoon that we have some syringes in our stock and on the floor that are contaminated/appear to have mold inside of the packaging.Nurses went through items on the floor and found some that appear contaminated to various degrees.More were found in our par bar bin.All the ones that have been found have the same lot # 9242988, exp date of 07/31/2024." "i know one of our staff members had a near miss with it and had medication drawn into syringe and moved toward i.V.To get ready to administer medication before it was noticed." "medwatch report: a black colored substance, suspected as mold was found on a syringe before drawing up the medication.After further review of additional syringes, some were noticed with black speckles of similar substance inside the sterile pouch." e.4.Fda notified? yes h3 other text : see section h.10.

Event Description

It was reported that mold was found in the bd luer-lok¿ syringe sterile, single use before use.This occurred on 10 separate occasions, but the dates are unknown.The following information was provided by the initial reporter: "i was notified this afternoon that we have some syringes in our stock and on the floor that are contaminated/appear to have mold inside of the packaging.Nurses went through items on the floor and found some that appear contaminated to various degrees.More were found in our par bar bin.All the ones that have been found have the same lot # 9242988, exp date of 07/31/2024." "i know one of our staff members had a near miss with it and had medication drawn into syringe and moved toward i.V.To get ready to administer medication before it was noticed.".

Manufacturer Narrative

H.6.Investigation summary 1 loose 5ml syringe with attached needle and an opened blister package.Both covered in large amounts of what appeared to be grease.The syringe had majority of the foreign matter on its flanges outside the fluid path.The package had the foreign matter residue on the inside of the top and bottom webs.- 1 sealed 5ml syringe with foreign matter observed inside the package, both on the product and the inside of the packaging.The syringe had what appeared to be grease around the flange, outside the fluid path.The inside of the package had the fm residue in the area where it came in contact with the syringe flange.A sealed sample was submitted for microbiological testing to confirm presence of any growth.A sample was also submitted for ftir testing to help identify the foreign matter observed one (1), bd 5ml luer-loktm syringe lot#9242988, catalog # 309646 with visual foreign matter was tested for the presence of mold contamination by the bd canaan microlab.Since no evidence of mold growth was observed on any of the agar plates, mold contamination may be ruled out as the contaminant of the bd 5ml luer-loktm syringe lot#9242988, catalog # 309646 examined during this investigation.Ftir (fourier transform infrared ) analysis was completed on the dark material observed on the surface of the sample.A small portion of this material was removed from the sample and prepared for ftir spectral analysis.The spectral analysis shows that this material is most likely grease.Potential root cause for the grease foreign matter defect is associated with the assembly process.No corrective actions are necessary based on the defective rate identified.Batch 9242988 is considered in compliance with our product specification requirements.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD LUER-LOK SYRINGE STERILE, SINGLE USE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9677479
• MDR Text Key: 191535617
• Report Number: 1213809-2020-00067
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096467
• UDI-Public: 30382903096467
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: 309646
• Device Catalogue Number: 309646
• Device Lot Number: 9242988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Initial Date Manufacturer Received: 01/17/2020
• Initial Date FDA Received: 02/06/2020
• Supplement Dates Manufacturer Received: 01/17/2020; 01/17/2020
• Supplement Dates FDA Received: 03/04/2020; 03/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other