MAUDE Adverse Event Report: BECTON DICKINSON PREFILLED SALINE SYRINGE

Catalog Number 3038418354

Device Problem Nonstandard Device (1420)

Patient Problems Erythema (1840); Unspecified Infection (1930); Pain (1994); Swelling (2091); Chills (2191)

Event Type  malfunction  

Event Description

Caller had a shot to his right knee on (b)(6) 2018 and immediately experienced swelling, pain, chills and redness to the knee.As a result of these, an emergency surgery was done on (b)(6) 2018 at the (b)(6) hospital.He was treated with antibiotics through a pic line for 30 days for infection.His md called him today (b)(6) 2018 and informed him that becton dickinson has just recalled the syringes from the lot that was used on him.

• Brand Name: PREFILLED SALINE SYRINGE
• Type of Device: PREFILLED SALINE SYRINGE
• Manufacturer (Section D): BECTON DICKINSON
• MDR Report Key: 7548949
• MDR Text Key: 109511093
• Report Number: MW5077466
• 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: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 3038418354
• Device Lot Number: 712212C
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 82