MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ SYRINGE LL W/BLUNT PLASTIC CANN; INTRAVENOUS LINE/SYRINGE LUER CONNECTOR

Catalog Number	303346
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: n/a.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that a bd¿ syringe ll w/blunt plastic can had a sharp plunger.
Additional Manufacturer Narrative
Correction: this mdr was over-reported.This complaint was made for an empty package, which is not a reportable malfunction.The sharp protrusion on the syringehas already been reported and was captured on mfr report # 1213809-2018-00827.
Event or Problem Description
It was reported that a bd¿ syringe ll w/blunt plastic can had a sharp plunger.
Additional Manufacturer Narrative
In section h.10 of the previously submitted mdr, sections d.1 was incorrectly referenced as the medical device expiration date.This supplemental mdr is being submitted to correct those references to show the following: d.4 medical device expiration date.
Event or Problem Description
It was reported that a bd¿ syringe ll w/blunt plastic cann had a sharp plunger.

• Brand Name: BD¿ SYRINGE LL W/BLUNT PLASTIC CANN
• Common Device Name: INTRAVENOUS LINE/SYRINGE LUER CONNECTOR
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8152664
• Report Number: 1213809-2018-00878
• Device Sequence Number: 16204155
• Product Code: FMI
• UDI-Device Identifier: 30382903033462
• UDI-Public: 30382903033462
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K974363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/04/2019

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
• Operator of Device: Other
• Device Catalogue Number: 303346
• Device Lot Number: 8203555
• Initial Date Received by Manufacturer: 11/26/2018
• Supplement Date Received by Manufacturer: 11/26/2018; 11/26/2018
• Initial Report FDA Received Date: 12/11/2018
• Supplement Report FDA Received Date: 01/28/2019; 02/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other