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

Catalog Number 301027

Device Problem Material Twisted/Bent (2981)

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

Event Date 07/24/2018

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 the bd plastic non-sterile luer-lok¿ tip syringes were bent.There was no report of exposure, injury, or medical intervention.

Manufacturer Narrative

Correction: due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacture: yes.Investigation summary: a single loose 5ml syringe was received in a plastic bag, reported to be from batch #8092535 (b)(4).The syringe was observed to be straight with no damage to flange or barrel.However, it had a distorted stopper, part of which was jammed between the barrel wall and the plunger.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.Potential root cause for the distorted stopper defect is associated with the assembly process.No corrective actions are necessary based on the defective rate identified.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 the bd plastic non-sterile luer-lok¿ tip syringes were bent.There was no report of exposure, injury, or medical intervention.

• Brand Name: BD PLASTIC NON-STERILE LUER-LOK¿ TIP SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7809310
• MDR Text Key: 118248318
• Report Number: 1213809-2018-00557
• Device Sequence Number: 1
• Product Code: FMF
• 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,other
• Type of Report: Initial,Followup
• Report Date: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 301027
• Device Lot Number: 8092535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2018
• Date Manufacturer Received: 08/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other