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

Catalog Number 309702

Device Problems Leak/Splash (1354); Unsealed Device Packaging (1444); Defective Component (2292)

Patient Problem No Information (3190)

Event Date 01/14/2019

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 the integrity of the bd luer-lok¿ syringe was compromised and didn't provide a sterile seal due to "potentially defective" stopper, which resulted in leakage.The syringes are reportedly used in the compounding of various pharmaceuticals, and container closure integrity tests are performed on the syringes using a pti system, along with visual inspection from quality assurance.They are used in tandem with a "baxa pump" to dispense at "less than 50 psi" and fill between "1.8mland 3ml".The malfunctioning syringe was found during use leaking "from behind the second seal of the plunger stopper", and visible liquid was found between two stopper seals.This mdr was created to capture 1 of 6 related incidents that occurred on separate dates.As reported by the customer, "we believe that the device integrity is compromised and does not provide a sterile seal due to a potentially defective plunger stopper.These syringes are used in the compounding of various pharmaceuticals which recognize a sterile device integrity for at leas 134 days.We perform container closure integrity using a pti system and perform 100% visual inspection with qa aql inspection.We found that the 3cc syringe lot in question are leaking from behind the second seal of the plunger stopper and are failing to maintain closure integrity.There is visible liquid between the 2 stopper seals and in some cases the liquid is on the plunger behind the second seal.The syringes are pumped with a baxa pump that dispenses at less than 50 psi.Fill volumes are 1.8ml and 3ml".

Manufacturer Narrative

Investigation: two bags of 3ml samples were received and evaluated.One bag was labeled ¿crooked plungers¿ and contained 5 assembled 3ml syringes filled with 3ml of clear liquid and tip caps attached.No stopper angularity nor plunger rod defects were observed in these samples.3 out of 5 syringes had liquid past the first stopper rib.When pushing on the plunger of all 5 samples ¿ the seal remained intact with no more liquid coming out.One bag was labeled ¿leaking plungers¿ and contained 14 assembled 3ml syringes filled with 3ml of clear liquid and tip caps attached.All of the stoppers were found to have liquid droplets past the first rib with moisture, but no droplets, observed behind the second rib in 2 of the samples.Furthermore, 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.No other complaints have been received for this batch and condition to date, therefore it is likely a potential root cause is associated with the way the product is being used and not with the manufacturing process.The syringes are manufactured in accordance with bd product specification and iso standard for syringes.The product is in compliance with those requirements.The defect was not confirmed to be associated with the manufacturing process.

Event Description

It was reported that the integrity of the bd luer-lok¿ syringe was compromised and didn't provide a sterile seal due to "potentially defective" stopper, which resulted in leakage.The syringes are reportedly used in the compounding of various pharmaceuticals, and container closure integrity tests are performed on the syringes using a pti system, along with visual inspection from quality assurance.They are used in tandem with a "baxa pump" to dispense at "less than 50 psi" and fill between "1.8mland 3ml".The malfunctioning syringe was found during use leaking "from behind the second seal of the plunger stopper", and visible liquid was found between two stopper seals.This mdr was created to capture 1 of 6 related incidents that occurred on separate dates.As reported by the customer, "we believe that the device integrity is compromised and does not provide a sterile seal due to a potentially defective plunger stopper.These syringes are used in the compounding of various pharmaceuticals which recognize a sterile device integrity for at leas 134 days.We perform container closure integrity using a pti system and perform 100% visual inspection with qa aql inspection.We found that the 3cc syringe lot in question are leaking from behind the second seal of the plunger stopper and are failing to maintain closure integrity.There is visible liquid between the 2 stopper seals and in some cases the liquid is on the plunger behind the second seal.The syringes are pumped with a baxa pump that dispenses at less than 50 psi.Fill volumes are 1.8ml and 3ml".

• Brand Name: BD LUER-LOK SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8425385
• MDR Text Key: 139082521
• Report Number: 1213809-2019-00342
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903097020
• UDI-Public: 30382903097020
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 309702
• Device Lot Number: 8184886
• Date Manufacturer Received: 02/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other