MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. SYRINGE 10ML REG PR SALINE FILL SPKG; INTRAVASCULAR CATHETER

Model Number 306553

Device Problem Packaging Problem (3007)

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

Event Date 04/08/2020

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.

Event Description

It was reported that syringe 10ml reg pr saline fill spkg had watermarking in the box.The following information was provided by the initial reporter: "material no: 306553 batch no: 9011582 it was reported that stains were noticed inside the packaging.Event description per attached email states: supposed to be a sterile syringe but has stains inside the package.Date received for intake: 13-apr-2020".

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.Returned to manufacturer on: 4/27/2020.Investigation: a device history record review was performed for provided lot number 9011582 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, a physical sample was provided for evaluation by our quality engineer team.Through examination of the sample, foreign matter was observed on the product packaging.It has been determined that this incident resulted during the steam sterilization process.The integrity of the product and the sterile barriers have not been affected.Furthermore, microbial permeability testing, cytotoxicity testing, and testing for residual solvents and volatile species has been completed on the packages displaying the brownish stain.The testing confirmed that they do not present any risk to the use of the product and have no impact on the effectiveness, sterility, quality or safety of bd posiflush¿ sf 10ml saline flush syringe.

Event Description

It was reported that syringe 10ml reg pr saline fill spkg had watermarking in the box.The following information was provided by the initial reporter: "material no: 306553 batch no: 9011582.It was reported that stains were noticed inside the packaging.Event description per attached email states: supposed to be a sterile syringe but has stains inside the package.Date received for intake: 13-apr-2020.".

• Brand Name: SYRINGE 10ML REG PR SALINE FILL SPKG
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 10022726
• MDR Text Key: 204247562
• Report Number: 9616657-2020-00068
• 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: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2021
• Device Model Number: 306553
• Device Catalogue Number: 306553
• Device Lot Number: 9011582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2020
• Date Manufacturer Received: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other