MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYR 10ML SURESCRUB POSIFLUSH SALINE; SALINE VASCULAR ACCESS 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	05/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple medical device types reported to be involved.The information for the additional device type is as follows: common device name: alcohol pad, device disinfectant, medical device type: lkb.There were multiple pma / 510(k)#s reported to be involved.The information for each 510(k) number is as follows: pma / 510(k)#: k161552, pma / 510(k)#: k121655.Device evaluated by mfr: 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 leaked in the sealed package.The following information was provided by the initial reporter: "liquid leaked/exploded.".
Additional Manufacturer Narrative
One photo was provided.It shows a syringe in its sealed packaging flow wrap.The alcohol pad looks wet.From the photo we can¿t confirm how the leakage occurred and if any barrel damage induced it.Root cause is undetermined.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 leaked in the sealed package.The following information was provided by the initial reporter: "liquid leaked/exploded".

• Brand Name: SYR 10ML SURESCRUB POSIFLUSH SALINE
• Common Device Name: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8667645
• Report Number: 1911916-2019-00558
• Device Sequence Number: 2039530
• Product Code: NGT
• UDI-Device Identifier: 30382903065593
• UDI-Public: 30382903065593
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.10.
• 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): 06/18/2019

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: 8261704
• Initial Date Received by Manufacturer: 05/20/2019
• Supplement Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 06/04/2019
• Supplement Report FDA Received Date: 06/18/2019
• 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