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

Catalog Number 305210

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 10/29/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).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 before use of the bd¿ oral syringes with tip caps there was mixed product in the package.There was no report of exposure, injury, or medical intervention noted.

Manufacturer Narrative

Investigation summary: one photo was received and evaluated.The photo depicts a single loose 3ml luer-lok syringe with standard print in a person¿s hand.Device history record review revealed that the packaging batch 8236730 consisted of 2 assembly batches.One of the batches was #8251568 ¿ amber oral syringes.Immediately prior to the assembly batch #8251568, a 3ml standard print product was manufactured on the same machine.Investigation revealed that the amber oral product was incompatible with the vision system on the machine the assembly batch 8251568 was manufactured on.The vision system, when operational, checks for barrel tip configuration to detect luer lok versus slip tip.Product batch was released and accepted under deviation.Probable root cause: poor line clearance.Since the 3ml luer-lok product was manufactured immediately prior to one of the assembly batches, it is possible that an incomplete line clearance resulted in a 3ml luer-lok syringe to get mixed in with the amber oral product.Corrective action: 1.Line clearance reinforcement training will be conducted for all relevant personnel.2.Vision system will be upgraded on this machine to be able to work with amber barrels.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 before use of the bd¿ oral syringes with tip caps there was mixed product in the package.There was no report of exposure, injury, or medical intervention noted.

• Brand Name: BD¿¿ ORAL SYRINGE WITH TIP CAP
• Type of Device: LIQUID MEDICATION DISPENSER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8085927
• MDR Text Key: 127863933
• Report Number: 1213809-2018-00777
• 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: 12/27/2018

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 Catalogue Number: 305210
• Device Lot Number: 8236730
• Initial Date Manufacturer Received: 10/29/2018
• Initial Date FDA Received: 11/19/2018
• Supplement Dates Manufacturer Received: 10/29/2018
• Supplement Dates FDA Received: 12/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other