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

Catalog Number 305210

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 01/17/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: n/a.Initial reporter phone#: (b)(6).Initial reporter address: (b)(6).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¿ oral syringe with tip cap had foreign matter in the syringe.No serious injury or medical intervention was reported.

Event Description

It was reported that bd¿ oral syringe with tip cap had foreign matter in the syringe.No serious injury or medical intervention was reported.

Manufacturer Narrative

Investigation: one photo and 2 loose tip caps were received and evaluated.The tip caps were observed to have numerous brown and black embedded foreign matter particles.Several particles were larger than level 3 in size, which is rejectable per product specification.Furthermore, 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 potential root cause for the embedded foreign matter defect is associated with the molding process.

• 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: 8299145
• MDR Text Key: 134899323
• Report Number: 1213809-2019-00148
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• 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
• Date Manufacturer Received: 01/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other