MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE ORAL 10ML CLEAR; LIQUID MEDICATION DISPENSER

Catalog Number 305219

Device Problems Material Disintegration (1177); Device Markings/Labelling Problem (2911)

Patient Problem No Information (3190)

Event Date 02/06/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Device manufacture date: unknown.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Investigation conclusion: unconfirmed: bd was not able to confirm the customer¿s indicated failures.Root cause description: no root cause can be determined as no samples were received.

Event Description

It was reported that over 10 days of use the markings on a syringe oral 10ml clear came off.Customer stated, "complaint that i experienced recently as my son was taking antibiotics and we were using the 10ml oral bd syringe to draw up the liquid.Over the course of the 10 day antibiotic use we were only washing the syringe with regular dish soap between uses.By the mid-way through the prescription almost all of the markings had come off the syringe so that we were guessing on where the 10ml line appeared.".

• Brand Name: SYRINGE ORAL 10ML CLEAR
• Type of Device: LIQUID MEDICATION DISPENSER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 8373931
• MDR Text Key: 137527191
• Report Number: 1213809-2019-00283
• Device Sequence Number: 1
• Product Code: KYW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305219
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other