MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ NORMAL SALINE SYRINGE; SALINE VASCULAR ACCESS FLUSH

Model Number 306547

Device Problem Leak/Splash (1354)

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

Event Date 05/27/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(4).Investigation summary: no samples or photos were provided by the customer for investigation.These syringes are not designed to draw blood.They are designed to flush the iv line by pressing the plunger rod down, not to pull it up.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor the associated assembly batches.Investigation conclusion: this is the 1st complaint for lot #44900 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: the reported condition can be attributed to off label use.Based on the symptom reported and the description provided this is not related to the manufacturing process.Based on the symptom reported and the description provided this is not related to the manufacturing process.Therefore, no additional actions will be performed.Rationale: capa not required at this time.

Event Description

It was reported that the bd posiflush¿ normal saline syringe was used to flush a cvc when blood leaked past the plunger during use.The following information was provided by the initial reporter: "we have an additional product issue reported on bd posiflush manufacture number 306547, lot number 0044900.Detailed description: syringe was used to flush a cvc, blood leaked outside the plunger area.Product was discarded.Incident reported on (b)(6) 2020.".

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• 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: 10135609
• MDR Text Key: 201246353
• Report Number: 1911916-2020-00539
• 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: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2023
• Device Model Number: 306547
• Device Catalogue Number: 306547
• Device Lot Number: 0044900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2020
• 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