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

Catalog Number 306553

Device Problems Problem with Sterilization (1596); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/28/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 before use of the bd posiflush¿ sf saline syringe that green like tape went across the top of the packaging that caused the package to be opened leaving the syringe non sterile.There was no report of exposure, serious injury or medical intervention.

Event Description

It was reported that before use of the bd posiflush sf saline syringe that green like tape went across the top of the packaging that caused the package to be opened leaving the syringe non sterile.There was no report of exposure, serious injury or medical intervention.

Manufacturer Narrative

Six physical samples and one picture sample belonging to lot number 8150692 were received for evaluation by our quality engineer.A device history record review did not reveal any quality issues during the production of lot number 8150692 that could have contributed to this incident.Upon inspection of the samples, green tape was observed on the product packaging.The green tape occurs during the attachment of the last packaging labels.The green tape prevents a proper seal.This issue is related to the labeling supplier and therefore, a supplier correction action request has been submitted to further investigation this issue and prevent its reoccurrence.This issue will continue to be monitored by our quality team for emerging trends.

• Brand Name: BD POSIFLUSH¿ SF SALINE SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 7889168
• MDR Text Key: 120973106
• Report Number: 9616657-2018-00041
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 11/06/2018

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: Other
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 306553
• Device Lot Number: 8150692
• Initial Date Manufacturer Received: 08/28/2018
• Initial Date FDA Received: 09/19/2018
• Supplement Dates Manufacturer Received: 08/28/2018
• Supplement Dates FDA Received: 11/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other