MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH¿ SF SALINE SYRINGE; SALINE FLUSH

Catalog Number 306553

Device Problems Contamination (1120); Difficult to Open or Remove Packaging Material (2922)

Patient Problem No Patient Involvement (2645)

Event Date 01/11/2018

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.No lot # provided.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that when the user separates the bd posiflush¿ sf saline syringe, the packaging, each syringe side tears open contaminating the other syringes before use.No serious injury or medical intervention noted.

Manufacturer Narrative

Additional information: medical device lot #: 7170621.Medical device expiration date: 05/31/2020.Device manufacture date: 06/19/2017.Investigation summary: lot number / product family history.Complaint trending review of the lot for this is issue reveals this is the first complaint.The review of the lot dhr did not indicate any anomaly which could have contributed to this issue.The non-conformances were reviewed for this batch; there were no non-conformances associated with this defect.Sample investigation.The returned sample was inspected and the samples were confirmed to have presence of poor perforation.Investigation conclusion: root cause.A single root cause is not fully assignable in this case but it may be associated with a frequency on the perforation station.There were non-conformances associated with this failure mode for the lot number listed in connection with this complaint.

• Brand Name: BD POSIFLUSH¿ SF SALINE SYRINGE
• Type of Device: SALINE FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 7238045
• MDR Text Key: 98982059
• Report Number: 9616657-2018-00001
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065531
• UDI-Public: 30382903065531
• Combination Product (y/n): N
• PMA/PMN Number: K153481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 306553
• Device Lot Number: 7170621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Initial Date Manufacturer Received: 01/11/2018
• Initial Date FDA Received: 02/02/2018
• Supplement Dates Manufacturer Received: 01/11/2018
• Supplement Dates FDA Received: 02/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other