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

Catalog Number	306507
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/26/2017
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 with the use of the 3 ml bd¿ pre-filled normal saline syringe when using the franklin flush 3 ml syringe filled to 3 ml, the nurses frequently experience a high pressure alarm and they syringe pump stops infusing.Some of the flush syringes have irregularities inside the hub as compared to an empty bd syringe.There was no report of injury or medical intervention.
Additional Manufacturer Narrative
Updated information on page g reflect the additional information provided.On 1/18/2018, a corrected awareness date was added.The additional information for this is as follows: date received by manufacturer: 10/18/2017.
Additional Manufacturer Narrative
Results: bd received samples and photos from the customer facility for investigation.The samples and photos were evaluated and the customer¿s indicated failure mode for broken/damaged syringe with the incident lot was not observed.Additionally, bd was unable to determine the specific lot number associated with this complaint.Therefore, a review of the device history record could not be conducted.Conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure mode.Unable to determine root cause.
Additional Manufacturer Narrative
Updated information on page g reflect the additional information provided.A corrected awareness date is 10/26/2017, the previous date was entered in error.Date received by manufacturer: 10/26/2017.

• Brand Name: BD¿ PRE-FILLED NORMAL SALINE SYRINGE
• Common Device Name: FLUSH
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; 9630 south 54th street; franklin WI 53132
• MDR Report Key: 7060082
• Report Number: 2134319-2017-00004
• Device Sequence Number: 10780441
• Product Code: FOZ
• UDI-Device Identifier: 30382903065074
• UDI-Public: 30382903065074
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K982558
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/21/2018

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: Nurse
• Device Catalogue Number: 306507
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2017
• Initial Date Received by Manufacturer: 10/26/2017
• Supplement Date Received by Manufacturer: 10/26/2017; 10/18/2017; 10/26/2017
• Initial Report FDA Received Date: 11/27/2017
• Supplement Report FDA Received Date: 01/02/2018; 01/25/2018; 02/21/2018
• 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