MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ NORMAL SALINE 10ML FILL IN 10ML SYRINGE; FLSUH SYRINGE

Catalog Number	306500
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.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 two bd¿ normal saline 10ml fill in 10ml syringes had holes in the syringe, and the event was found when attempting to flush an occluded piv.Customer¿s verbatim: ¿it was reported that two syringes from the same lot number have holes in the syringes found when attempting to flush an occluded piv.¿.
Event or Problem Description
It was reported that two bd¿ normal saline 10ml fill in 10ml syringes had holes in the syringe, and the event was found when attempting to flush an occluded piv.Customer¿s verbatim: ¿it was reported that two syringes from the same lot number have holes in the syringes found when attempting to flush an occluded piv.¿.
Additional Manufacturer Narrative
Investigation: no photos or physical samples that display the reported condition were available for investigation.A device history review was performed for lot 801711a, no deviations or non-conformances were identified during the manufacturing process that could have contributed to the reported issue.Inspection records verified in-process and release inspections met required specifications.Retained samples of the reported lot were evaluated, no drops of liquid or holes were observed in the product.Based on the available information we are not able to identify a root cause at this time.

• Brand Name: BD¿ NORMAL SALINE 10ML FILL IN 10ML SYRINGE
• Common Device Name: FLSUH SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; 9630 south 54th street; franklin WI 53132
• MDR Report Key: 8428358
• Report Number: 2134319-2019-00103
• Device Sequence Number: 1663937
• Product Code: FOZ
• UDI-Device Identifier: 30382903065005
• UDI-Public: 30382903065005
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 06/07/2019

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: 01/16/2021
• Device Catalogue Number: 306500
• Device Lot Number: 801711A
• Initial Date Received by Manufacturer: 02/27/2019
• Supplement Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 03/18/2019
• Supplement Report FDA Received Date: 06/07/2019
• 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