MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE

Catalog Number 306572

Device Problem Insufficient Information (3190)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 10/09/2018

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the bd posiflush¿ xs pre-filled flush syringe was being used as a flush after parenteral nutrition.It was reported that the patient¿s ¿connection visit¿ was canceled as per instructions from her oncology team, pending ¿further blood tests have been done as they feel the pn is affecting her blood and fluid levels and affecting her breathing¿.

Manufacturer Narrative

As no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Regular inspections are performed during the production of the xs product and finished products are sampled for additional inspection.The inspections performed verify that the sterile barrier remains intact and that the product meets standard requirements.There is no evidence to support that the posiflush syringe was responsible for the reported reaction.A potential contributory factor may be the other medicinal products in use or administered at the time the patient's port was flushed.An exact cause could not be determined for the reported incident.Complaints received for this device and defect will continue to be monitored by our quality team for emerging trends.Dhr could not be reviewed as no lot number is available.

Event Description

It was reported that the bd posiflush xs pre-filled flush syringe was being used as a flush after parenteral nutrition.It was reported that the patient¿s ¿connection visit¿ was canceled as per instructions from her oncology team, pending ¿further blood tests have been done as they feel the pn is affecting her blood and fluid levels and affecting her breathing¿.

• Brand Name: BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 8020229
• MDR Text Key: 125513323
• Report Number: 9616657-2018-00047
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 306572
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention