MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ PRE-FILLED NORMAL SALINE FILLED FLUSH SYRINGE; INTRAVASCULAR CATHETER

Catalog Number	306500
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The date received by manufacturer has been used for this field.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 the bd¿ pre-filled normal saline filled flush syringe had a cracked barrel, causing saline to leak.There was no report of exposure, injury, or medical intervention.
Additional Manufacturer Narrative
One sample unit belonging to lot number 802411d and product code 306500 was provided for evaluation by our quality engineer.A device history record review did not reveal any deviations, non-conformances, or out of specification conditions related to the manufacture of lot number 802411d.Upon visual inspection of the provided sample, the syringe was observed to be removed from the flow wrap packaging and it had a large crack along the barrel of the syringe.One-hundred and twenty retained samples of the same lot number were obtained from the manufacturing facility for further investigation.Through visual inspection of the retained samples, no damages were observed to the syringe barrels or plungers.It is possible that the observed crack occurred at the labeler (prior to the application of the flow wrap packaging) or at the station which places the product within the carton (after the application of the flow wrap packaging).As the returned sample was removed from the packaging, it is not possible to determine which station the damage occurred at.The current risk management documents in place contain steps related to this issue.The existing conditions, controls, hazards, and ratings in these documents do not require updates at this time.There is currently no trend for cracked barrels within the related manufacturing facility and this incident appears to be an isolated occurrence.Corrective action has not been determined necessary at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that the bd pre-filled normal saline filled flush syringe had a cracked barrel, causing saline to leak.There was no report of exposure, injury, or medical intervention.

• Brand Name: BD¿ PRE-FILLED NORMAL SALINE FILLED FLUSH SYRINGE
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; 9630 south 54th street; franklin WI 53132
• MDR Report Key: 7890269
• Report Number: 2134319-2018-00113
• Device Sequence Number: 16180174
• Product Code: FOZ
• UDI-Device Identifier: 30382903065005
• UDI-Public: 30382903065005
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/16/2018

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
• Operator of Device: Other
• Device Expiration Date: 01/23/2021
• Device Catalogue Number: 306500
• Device Lot Number: 802411D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Initial Date Received by Manufacturer: 08/29/2018
• Supplement Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 09/19/2018
• Supplement Report FDA Received Date: 10/16/2018
• 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