MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BARREL 10CC LL W/SILICONE NO BD LOGO BNS; SYRINGE BARREL

Catalog Number 304157

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 01/09/2019

Event Type  malfunction  

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 10,285 syringe barrels 10cc ll w/silicone no bd logo bns exhibited "pools/droplets" of excess silicone in them once the plunger was inserted.

Event Description

It was reported that 10,285 syringe barrels 10cc ll w/silicone no bd logo bns exhibited "pools/droplets" of excess silicone in them once the plunger was inserted.

Manufacturer Narrative

Investigation summary: four loose 10ml ll syringe barrels were received and visually inspected.Two of the barrels had unknown plunger rod and stopper assemblies and were in the bottom out position.The plungers with stoppers were pulled back to evaluate silicone presence.It was observed that silicone residue was present on the stopper and the end of the barrel.The amount of silicone appears to be towards the upper side of the product specification but still acceptable.As for the two empty barrels, it was observed that one of them had a smooth uniform coating to the point that it was barely visible other than the noticeable sheen.The other empty barrel had slightly more silicone with a small build up at the bottom, but both empty barrels were observed to have a normal and expected amount of silicone for this product per specification.Although, it appears that excessive silicone is present in 2 of the 4 samples received.It is not clear if the excessive silicone came from the barrel siliconization process or from the stopper siliconization process.Therefore, the root cause is considered undetermined at this point.Moreover, it is important to be aware that the silicone observed is an integral part of the syringe, enabling it to perform as required in various clinical applications.Bd applies silicone to its syringes under carefully controlled conditions that are monitored for compliance to both bd standards as well as meeting the requirements of the iso standard for syringes.In our manufacturing environment, bd targets applying a quantity of silicone considerably less than the maximum amount specified in iso.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.Our production records for silicone show that the silicone quantity was within specification for catalog number 304157.No corrective actions recommended since root cause is undetermined and samples received were confirmed as acceptable.

• Brand Name: BARREL 10CC LL W/SILICONE NO BD LOGO BNS
• Type of Device: SYRINGE BARREL
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8287274
• MDR Text Key: 134579398
• Report Number: 1213809-2019-00126
• Device Sequence Number: 1
• Product Code: KDC
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 304157
• Device Lot Number: 8117555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2019
• Date Manufacturer Received: 01/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other