MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE TIP CAP BULK STERILE CONVENIENCE PAK; LIQUID MEDICATION DISPENSER

Catalog Number 305822

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 07/02/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Pma/510(k)#: class i exempt.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd syringe tip cap bulk sterile convenience pak was missing the label.This occurred on 3 occasions before use.The following information was provided by the initial reporter: missing label on carton box.No label on 3 carton boxes.

Manufacturer Narrative

H.6.Investigation: two photos of 1000-count tip cap boxes were received and evaluated.One photo displayed two cubes with each cube containing one box missing the label.One photo showed three individual boxes without labels.Potential root cause for the missing label defect is associated with an equipment failure.This was most likely due to a build-up of adhesive on the roller that separates the label from the backing.The buildup could have caused the labels to become stuck to the roller instead of being applied to the box.The brass roller was removed from the labeler and thoroughly cleaned to remove all adhesive on 8/9/2019.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.

Event Description

It was reported that bd syringe tip cap bulk sterile convenience pak was missing the label.This occurred on 3 occasions before use.The following information was provided by the initial reporter: missing label on carton box.No label on 3 carton boxes.

• Brand Name: BD SYRINGE TIP CAP BULK STERILE CONVENIENCE PAK
• Type of Device: LIQUID MEDICATION DISPENSER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8799631
• MDR Text Key: 151491154
• Report Number: 1213809-2019-00751
• Device Sequence Number: 1
• Product Code: KYW
• Combination Product (y/n): N
• PMA/PMN Number: SEE H.10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 305822
• Device Lot Number: 9078939
• Date Manufacturer Received: 07/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other