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

Catalog Number 305210

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Information (3190)

Event Date 02/01/2019

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).Device evaluated by mfr? 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 2 bd¿ oral dispensing syringes had jammed stoppers.

Manufacturer Narrative

Investigation: three photos were received and evaluated.Two 3ml amber oral syringes were depicted in the photos.Both syringes appeared to have jammed stopper defects.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 jammed stopper defect is associated with the assembly process.

Event Description

It was reported that 2 bd¿ oral dispensing syringes had jammed stoppers.

• Brand Name: BD¿ ORAL DISPENSING SYRINGE
• Type of Device: LIQUID MEDICATION DISPENSER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8347746
• MDR Text Key: 136611042
• Report Number: 1213809-2019-00205
• 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: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305210
• Device Lot Number: 8303761
• Date Manufacturer Received: 02/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other