MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ ORAL SYRINGE; LIQUID MEDICATION DISPENSER

Catalog Number UNKNOWN

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 11/07/2018

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed in sections and the (b)(4) fda registration number has been used for the manufacture report number.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 there were "black particles" on the unspecified bd¿ oral syringe, and a "hair" was found in another syringe.

Manufacturer Narrative

After further review of the information provided, the catalog # 54-5030, syringe ent feed orange 30cc 100ea/ca filed for this report was found to not be a bd product, deeming this complaint non-reportable.

Event Description

It was reported that there were "black particles" on the unspecified bd oral syringe, and a "hair" was found in another syringe.

• Brand Name: UNSPECIFIED BD¿ ORAL SYRINGE
• Type of Device: LIQUID MEDICATION DISPENSER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8137976
• MDR Text Key: 129597982
• Report Number: 2243072-2018-01741
• Device Sequence Number: 1
• Product Code: KYW
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• 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: 12/13/2018

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/16/2018
• Initial Date FDA Received: 12/06/2018
• Supplement Dates Manufacturer Received: 11/16/2018
• Supplement Dates FDA Received: 12/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other