MAUDE Adverse Event Report: MALLINCKRODT 30327 12CC SALINE SYRINGE {CAN} (10CC)

Model Number 8881570121

Device Problems Nonstandard Device (1420); Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Endocarditis (1834); Fever (1858)

Event Date 07/01/2013

Event Type  Other  

Event Description

It was reported to covidien on (b)(4) 2013 that a customer had an issue with a saline syringe.The customer reports via the medwatch event report that the pt was tested and was positive for polymicrobial bacteremia.The diagnosis was endocarditis.The frequency and route used, 10 ml gd picc line 042.The customer further reported that this pt gets daily iv therapy.The customer reports the pt was likely to have spiked a fever and as a result, a blood culture was drawn.The customer reports there were four different bacteria's in the blood cultures.The pt was treated for the bacteria and the pt status is unknown at this time, as the pt is no longer a pt at their facility.

Manufacturer Narrative

Submit date: (b)(4) 2014.An investigation is currently underway, upon completion, the results will be forwarded.Medwatch report # (b)(4).

• Brand Name: 30327 12CC SALINE SYRINGE {CAN} (10CC)
• Type of Device: SALINE SYRINGE
• Manufacturer (Section D): MALLINCKRODT; 7500 trans canada hwy; montreal qc H9R 5H8; CA H9R 5H8
• Manufacturer (Section G): MALLINCKRODT; 7500 trans canada hwy; montreal qc H9R 5H8; CA H9R 5H8
• Manufacturer Contact: elaine bishop ; 15 hampshire st.; mansfield, MA 02048 ; 5084524686
• MDR Report Key: 3601608
• MDR Text Key: 15264539
• Report Number: 1282497-2014-00001
• 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: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/31/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 8881570121
• Device Catalogue Number: 8881570121
• Device Lot Number: 13C0504
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/31/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other