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

Catalog Number 305209

Device Problem Volume Accuracy Problem (1675)

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

Event Date 08/22/2019

Event Type  malfunction  

Manufacturer Narrative

Device expiration date: unknown.Device manufacture date: 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 scale marking issue occurred with a syringe oral 10ml amber.The following information was provided by the initial reporter, "it was reported that the numbers are coming off of the syringes." 5 occurrences were reported.

Manufacturer Narrative

H.6.Investigation summary: two loose 10ml oral syringes were received in a biohazard bag and evaluated.One syringe was observed to have no scale markings and one syringe was observed to have faded scale markings.It is unclear what conditions the received syringes were subjected to.A physical unused sample from the same batch is needed for scale permanency testing.A physical sample is required for a more thorough evaluation and potential root cause determination.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.

Event Description

It was reported that scale marking issue occurred with a syringe oral 10ml amber.The following information was provided by the initial reporter, "it was reported that the numbers are coming off of the syringes." 5 occurrences were reported.

• Brand Name: SYRINGE ORAL 10ML AMBER
• Type of Device: LIQUID MEDICATION DISPENSER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9079487
• MDR Text Key: 194398842
• Report Number: 1213809-2019-00940
• 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,other
• Type of Report: Initial,Followup
• Report Date: 10/07/2019

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: 305209
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Initial Date Manufacturer Received: 08/28/2019
• Initial Date FDA Received: 09/17/2019
• Supplement Dates Manufacturer Received: 08/28/2019
• Supplement Dates FDA Received: 10/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other