MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. SYRINGE 10ML SALINE XS

Catalog Number 306572

Device Problems Fungus in Device Environment (2316); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 06/30/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that syringe 10 ml saline xs contained foreign matter.The following information was provided by the initial reporter: "it was reported that black foreign material was found on the tip of the syringe.(2 of 2) event description per attached email states: on june 13 and 30th two nurses opened a posiflush and upon inspection noted possible mold (black material) on the tip of the syringe.The products were not used on clients and were discarded.They were both from the same lot # 0044501.We have an additional 5 boxes remaining in our supply and i am requesting to have them replaced.".

Event Description

It was reported that syringe 10ml saline xs contained foreign matter.The following information was provided by the initial reporter: " it was reported that black foreign material was found on the tip of the syringe.(2 of 2) event description per attached email states: on june 13 and 30th two nurses opened a posiflush and upon inspection noted possible mold (black material) on the tip of the syringe.The products were not used on clients and were discarded.They were both from the same lot # 0044501.We have an additional 5 boxes remaining in our supply and i am requesting to have them replaced.".

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for evaluation?: yes.D.10.Returned to manufacturer on: (b)(6)2020.H.6.Investigation: a device history record review was performed for provided lot number 0044501 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, picture samples and representative samples were returned for evaluation by our quality engineer.As the representative samples did not show the defects captured within the picture samples, the picture samples were utilized to complete a thorough investigation.Through examination of the pictures, foreign matter was observed on the tips of the syringes.It has been determined that this foreign matter resulted from an error in the molding machine.After further inspection, burn marks were found on the tip caps manufactured within the molding machine.The cavity of the molding machine was cleaned and polished to prevent this defect from recurring.

• Brand Name: SYRINGE 10ML SALINE XS
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 10314471
• MDR Text Key: 203172318
• Report Number: 9616657-2020-00109
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 306572
• Device Lot Number: 0044501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Date Manufacturer Received: 07/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other