MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ ORAL DISPENSING SYRINGE; LIQUID MEDICATION DISPENSER

Catalog Number 305210

Device Problems Contamination of Device Ingredient or Reagent (2901); Device Markings/Labelling Problem (2911)

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

Event Date 03/20/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Medical device expiration date: n/a.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 foreign lubricant was found on the bd¿ oral dispensing syringe barrel before use, and the scale marking ink was "coming off".The following information was provided by the initial reporter: "ink coming off the syringe.Feels like lubrication on the syringe.".

Manufacturer Narrative

Investigation: 34 loose 1ml amber oral syringes were received inside an opened bag from batch #8263592 (p/n 305210).They were visually evaluated.Most of the syringes were observed to have missing print defect in the area between 1ml and zero line.The amount of print missing was rejectable per product specification.Missing print was found during production and adjustments were made to address the issue.Potential root cause for the missing print defect is associated with the marking process.Corrections took place at the time the defect was found during production.All visual inspections were performed as per requirement.A quality notification was issued for missing print during the manufacture of this batch.Adjustments were made and product requalified per applicable aql before production resumed.Batch 8263592 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.

Event Description

It was reported that foreign lubricant was found on the bd¿ oral dispensing syringe barrel before use, and the scale marking ink was "coming off".The following information was provided by the initial reporter: "ink coming off the syringe.Feels like lubrication on the syringe.".

• Brand Name: BD¿ ORAL DISPENSING SYRINGE
• Type of Device: LIQUID MEDICATION DISPENSER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8484915
• MDR Text Key: 141033391
• Report Number: 1213809-2019-00409
• Device Sequence Number: 1
• Product Code: KYW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 05/06/2019

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 Catalogue Number: 305210
• Device Lot Number: 8263592
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/20/2019
• Initial Date FDA Received: 04/04/2019
• Supplement Dates Manufacturer Received: 03/20/2019
• Supplement Dates FDA Received: 05/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other