MAUDE Adverse Event Report: BECTON DICKINSON NORMAL SALINE 10ML FILL IN 10ML SYRINGE; INTRAVASCULAR CATHETER

Catalog Number	306500
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 normal saline 10ml fill in 10ml syringe had foreign matter.The following was reported, " it was reported that a clump of debris was floating inside.Per pir form: lot 817411a with a clump of debris floating inside.".
Additional Manufacturer Narrative
H.6.Investigation: one product sample was returned to our quality team for investigation.Through visual inspection, a foreign particle was observed within the product.The material was removed from the barrel and characterization analysis was performed, identifying the material to consist of cardboard/paper product and silicone.A device history review was performed for reported lot 817411a, no deviations or non-conformances related to the reported issues were identified during the manufacturing process.The manufacturing site that supplies the syringe was notified of this incident.Through their investigation it was determined the particle likely originated from the assembly process.
Event or Problem Description
It was reported that a normal saline 10ml fill in 10ml syringe had foreign matter.The following was reported, " it was reported that a clump of debris was floating inside.Per pir form: lot 817411a with a clump of debris floating inside.".

• Brand Name: NORMAL SALINE 10ML FILL IN 10ML SYRINGE
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8433841
• Report Number: 2243072-2019-00520
• Device Sequence Number: 1163061
• Product Code: FOZ
• UDI-Device Identifier: 30382903065005
• UDI-Public: 30382903065005
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K011982
• 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
• Report Date (Section B): 05/31/2019

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 Expiration Date: 06/22/2021
• Device Catalogue Number: 306500
• Device Lot Number: 817411A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2019
• Initial Date Received by Manufacturer: 02/28/2019
• Supplement Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 03/19/2019
• Supplement Report FDA Received Date: 05/31/2019
• 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