MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306547

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/08/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: no samples were received.Investigation conclusion: this is the 1st complaint for lot # 9058568 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: root cause_ off label use.Rationale: no samples received.

Event Description

Material no.: 306547, batch/lot: 9058568.It was reported that during use of the syr 10 ml pump compatible saline 10 ml fil "after flushing the patient¿s dialysis catheter and blood was being drawn back into the syringe, the blood powerfully shot out around the plunger area of the syringe and splattered all over the patient''.The following information was provided by the initial reporter: i got a report today from our ambulatory dialysis unit regarding the bd saline syringe.The reported issue with the product is that after flushing the patient¿s dialysis catheter and blood was being drawn back into the syringe, the blood powerfully shot out around the plunger area of the syringe and splattered all over the patient.Per the report this particular issue with the product has happened on several occasions.There is a lot number included but per end user the lot number isn't always consistent with the product issue.

• Brand Name: SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 8645703
• MDR Text Key: 146793890
• Report Number: 1911916-2019-00521
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065470
• UDI-Public: 30382903065470
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/09/2019

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
• Device Operator: Other
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 306547
• Device Lot Number: 9058568
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/08/2019
• Initial Date FDA Received: 05/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other