MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ TIP SYRINGE WITHOUT NEEDLE

Catalog Number 301073

Device Problems Contamination (1120); Device Markings/Labelling Problem (2911); Material Integrity Problem (2978); Positioning Problem (3009)

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

Event Date 08/02/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.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 luer-lok¿ tip syringes without needles had foreign matter contaminates in them, as well as barrel damages, insecure stoppers, and scale marking issues.There was no report of exposure, injury, or medical intervention.

Manufacturer Narrative

Correction: due to an it issue beginning on 7/3/2018, 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: no.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.Dhr from (b)(4): release date: 11/14/2017.Released quantity was (b)(4).Printing and assembly records were reviewed as part of this dhr review.Print defects were found during the manufacture of this batch.Adjustments were made, including removing jammed part in dial, and product was requalified per applicable aql before production resumed.Batch 7313711 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.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 luer-lok¿ tip syringes without needles had foreign matter contaminates in them, as well as barrel damages, insecure stoppers, and scale marking issues.There was no report of exposure, injury, or medical intervention.

• Brand Name: BD LUER-LOK¿ TIP SYRINGE WITHOUT NEEDLE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7805555
• MDR Text Key: 118000796
• Report Number: 1213809-2018-00555
• Device Sequence Number: 1
• Product Code: FMF
• 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,foreign,other
• Type of Report: Initial,Followup
• Report Date: 09/11/2018

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: Other
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 301073
• Device Lot Number: 7313711
• Initial Date Manufacturer Received: 08/02/2018
• Initial Date FDA Received: 08/22/2018
• Supplement Dates Manufacturer Received: 08/02/2018
• Supplement Dates FDA Received: 09/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other