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	04/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.Medical device type: ngt, lkb.Pma/510(k)#: k161552, k121655.Investigation summary: three samples were received.They came in two plastic bags.Two of them have no packaging flow wrap, no tip cap and no saline solution.They have the plunger attached to the stopper.They are properly assembled and there is no gap between them.They were removed from barrel finding no defects.The other syringe came in an open packaging flow wrap.It has saline solution, tip cap and the plunger rod- rubber stopper.Again, there is no separation between the plunger rod and the rubber stopper.They were removed from the barrel finding no defects or any other issue.Failure mode could not be verified.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.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.Investigation conclusion: this is the 1st complaint for lot # 8261704 for this type of defect or symptom.There was no documentation for this type of defect during the entire production run of this batch.Root cause description: undetermined.
Event or Problem Description
It was reported that four syr 10ml surescrub posiflush saline experienced loose plungers.The following information was provided by the initial reporter: material no: 306559, lot no: 8261704.Per phone call: nurse reported that when pulling back to draw blood from port plunger came apart from the syringe.Nurse stated she had it happen 4 times within the last week.Per customer email rx from user facility, called in to report defective posiflush syringes.The plungers are falling apart and are wobbly.

• 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: 8545226
• Report Number: 1911916-2019-00407
• Device Sequence Number: 400394
• Product Code: NGT
• UDI-Device Identifier: 30382903065593
• UDI-Public: 30382903065593
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Report Date (Section B): 04/10/2019

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 04/24/2019
• 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