MAUDE Adverse Event Report: BD MEDICAL BD PREFILLED NORMAL SALINE SYRINGES .09% (TO FLUSH DRAIN); SALINE, VASCULAR ACCESS FLUSH

Lot Number 732911A

Device Problem Nonstandard Device (1420)

Patient Problem No Information (3190)

Event Date 04/01/2018

Event Type  No Answer Provided  

Event Description

Recall notification from phcy; ref a prefilled normal saline syringes.Reason for use: to flush a drain."is the product over-the-counter: no." notified by phcy - it was a recall.

• Brand Name: BD PREFILLED NORMAL SALINE SYRINGES .09% (TO FLUSH DRAIN)
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD MEDICAL
• MDR Report Key: 7609565
• MDR Text Key: 111483393
• Report Number: MW5077902
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 11/24/2020
• Device Lot Number: 732911A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/15/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Weight: 48