MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE ORAL 1ML CLEAR; LIQUID MEDICATION DISPENSER

Catalog Number 305217

Device Problem Break (1069)

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

Event Date 04/15/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that 200 syringe oral 1ml clear experienced product damage.The following information was provided by the initial reporter: material no.: 305217, batch no.: unknown.Per (b)(4) verbatim: health professional called to report that lately they have been received packs of oral syringes (cat # 305217, unknown lot) without the tip caps.

Event Description

It was reported that 200 syringe oral 1ml clear experienced product damage.The following information was provided by the initial reporter: material no.: 305217, batch no.: unknown.Per cs0007817 verbatim: health professional called to report that lately they have been received packs of oral syringes (cat # 305217, unknown lot) without the tip caps.

Manufacturer Narrative

Investigation: one opened bag of 1ml clear oral syringes was received, confirmed to be from batch #8236682 (p/n 305217).The bag was opened and contained no tip caps.Since the bag was opened it is not possible to confirm whether the tip caps were present in the sealed product.Though the reported defect could have occurred during manufacturing process, a sealed sample is required for proper investigation.Based on the available evidence, the defect was not identified in the samples received.The reported defect was not identified in the samples received.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.

• Brand Name: SYRINGE ORAL 1ML CLEAR
• Type of Device: LIQUID MEDICATION DISPENSER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8570613
• MDR Text Key: 145929777
• Report Number: 1213809-2019-00494
• 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: health professional,other
• Type of Report: Initial,Followup
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305217
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 04/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other