MAUDE Adverse Event Report: MALLINCKRODT CANADA UNKNOWN PREFILL; SALINE PREFILL

Model Number UNKNOWN PREFILL

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/13/2014

Event Type  Injury  

Event Description

It was reported to covidien on (b)(6) 2014 that a customer had an issue with a prefill syringe.The customer reports a piece of hair was found in the syringe that the nurse had already started administering to a patient.Upon further clarification from a covidien clinician, the reported incident is more clearly described as, the complainant noted that a "hair" was seen during injection of normal saline using a prefilled syringe.The injection was stopped.A "hair" remains in the syringe.Although no serious injury/medical intervention was reported, it is possible that microorganisms on the foreign body "hair" may transfer to the patient with injection.

Manufacturer Narrative

Submit date: 11/14/2014.An investigation is currently underway, upon completion the results will be forwarded.

Manufacturer Narrative

Samples were returned and forwarded to the supplier for investigation.A black hair or thread is inside the syringe, partially in the fluid pathway and partially between the plunger and the barrel of the syringe.The sample was analyzed and the analysis confirmed that the foreign matter is most likely hair.A device history record (dhr) review was completed for lot 14g1764 which was released for sale on (b)(6) 2014.There were no manufacturing related issues related to the complaint issued for this lot.A root cause analysis identified the most likely root cause of the foreign matter to come from the syringe supplier.The supplier has initiated a corrective action with their syringe supplier to further investigate this report.If additional information is received, the investigation will resume as needed.This complaint will be used for trending purposes.Per re-assessment by a covidien clinician, the complainant noted that a hair was seen during injection of normal saline using a prefilled syringe.The injection was stopped.A hair remains in the syringe.No patient injury was reported.As the contents in a prefilled syringe are sterilized prior to shipment- the hair can also be considered sterilized.Although it is remote that this hair would be transferred out of the syringe to the patient and cause harm/injury, this complaint was reported.

• Brand Name: UNKNOWN PREFILL
• Type of Device: SALINE PREFILL
• Manufacturer (Section D): MALLINCKRODT CANADA; 7500 trans canada hwy.; pointe claire; quebec ; CA
• Manufacturer (Section G): MALLINCKRODT CANADA; 7500 trans canada hwy.; pointe claire; quebec H9R 5H8; CA H9R 5H8
• Manufacturer Contact: elaine bishop ; 15 hampshire street; mansfield, MA 02048 ; 5084524686
• MDR Report Key: 4251819
• MDR Text Key: 15820726
• Report Number: 1282497-2014-00051
• Device Sequence Number: 1
• Product Code: NZW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PREFILL
• Device Catalogue Number: UNKNOWN PREFILL
• Device Lot Number: PR0004421
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1