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

Catalog Number 300912

Device Problems Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)

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

Event Date 08/20/2018

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 a bd syringe luer-lok¿ tip had a loose plunger that came off during aspiration.There was no report of exposure, serious injury or medical intervention.

Manufacturer Narrative

One loose 10ml assembled and one sealed 10ml packaged syringe was received and confirmed to be from batch #8033721 (p/n 300912).The samples were visually evaluated.One loose ¿ the syringe barrel and stopper were visually inspected for overall damage or creases no defects were observed.The plunger rod was pulled back and the stopper remained attached to the plunger rod tip.When the tip was blocked while pulling on the plunger rod, a vacuum formed inside the barrel.The syringe appeared used.The syringe had dried residue around stopper including stopper ribs.The same residue appeared on the plunger rod ribs and retaining ring.No additional testing could be performed.Packaged ¿ the packaged syringe was in a sealed package.Syringe was removed from package to perform evaluation, no creases or damage was observed.Plunger and stopper remain together when plunger rod is moved, no defects observed.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.Stopper leak test was performed on the sealed packaged syringe per procedure, no leakage or loss of suction was observed.Root cause not defined since defects were not confirmed in samples received.No corrective actions recommended since product defect was not confirmed.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.

Event Description

It was reported that a bd syringe luer-lok tip had a loose plunger that came off during aspiration.There was no report of exposure, serious injury or medical intervention.

• Brand Name: BD SYRINGE LUER-LOK¿ TIP
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7861092
• MDR Text Key: 119930685
• Report Number: 1213809-2018-00599
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903009122
• UDI-Public: 30382903009122
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 300912
• Device Lot Number: 8033721
• Date Manufacturer Received: 08/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other