MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYR 10ML SURESCRUB POSIFLUSH SALINE; SALINE, VASCULAR ACCESS FLUSH; PAD, ALCOHOL, DEVICE DISINFECTANT

Catalog Number	306559
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device type: ngt, lkb.Pma/510(k)#: k161552, k121655.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 syr 10ml surescrub posiflush saline experienced leakage.The following information was provided by the initial reporter: material no: 306559, batch no: 8261703.Event description per attached email states, "we had a saline flush today, same lot 8261703, in which the saline came out toward the nurses by the plunger end.We will enter an si, but wanted to let you all know as well.".
Additional Manufacturer Narrative
H.6.Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.
Event or Problem Description
It was reported that the syr 10ml surescrub posiflush saline experienced leakage.The following information was provided by the initial reporter: material no: 306559 batch no: 8261703 event description per attached email states, "we had a saline flush today, same lot 8261703, in which the saline came out toward the nurses by the plunger end.We will enter an si, but wanted to let you all know as well.".

• Brand Name: SYR 10ML SURESCRUB POSIFLUSH SALINE
• Common Device Name: SALINE, VASCULAR ACCESS FLUSH; PAD, ALCOHOL, DEVICE DISINFECTANT
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8579783
• Report Number: 1911916-2019-00441
• Device Sequence Number: 2359760
• Product Code: NGT
• UDI-Device Identifier: 30382903065593
• UDI-Public: 30382903065593
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K161552
• 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): 05/20/2019

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: 10/31/2020
• Device Catalogue Number: 306559
• Device Lot Number: 8261703
• Initial Date Received by Manufacturer: 04/18/2019
• Supplement Date Received by Manufacturer: 04/18/2019
• Initial Report FDA Received Date: 05/03/2019
• Supplement Report FDA Received Date: 05/20/2019
• 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