MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYR 10ML SURESCRUB POSIFLUSH SALINE; SALINE FLUSH

Catalog Number	306559
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
Material no.306559 batch, no.Unknown.It was reported that during use of the syr 10ml surescrub posiflush saline there is leakage at the plunger this occurred on 7 separate occasions but the date/time and or patient information is unknown.The following information was provided by the initial reporter: it was reported there is leakage at the plunger.
Additional Manufacturer Narrative
Investigation: 210 representative samples were received.Visual inspection was performed finding them all good.No defects were observed.They were tested performing a functional test, expelling the solution and no leakage was observed.Failure mode could not be verified.A device history record review could not be completed as no batch number was provided.
Event or Problem Description
Material no.306559 batch no.Unknown it was reported that during use of the syr 10ml surescrub posiflush saline there is leakage at the plunger this occurred on 7 separate occasions but the date/time and or patient information is unknown.The following information was provided by the initial reporter: it was reported there is leakage at the plunger.

• Brand Name: SYR 10ML SURESCRUB POSIFLUSH SALINE
• Common Device Name: SALINE FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8897051
• Report Number: 1911916-2019-00808
• Device Sequence Number: 19289966
• Product Code: NGT
• UDI-Device Identifier: 30382903065593
• UDI-Public: 30382903065593
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K161552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2019

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 Catalogue Number: 306559
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 07/26/2019
• Supplement Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 08/22/2019
• 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