MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%

Catalog Number 306572

Device Problem Packaging Problem (3007)

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

Event Date 04/17/2020

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 bd posiflush¿ xs pre-filled flush syringe nacl 0.9% had foreign matter inside.This was discovered before use.The following information was provided by the initial reporter: new, dirty bd saline xs syringes.

Event Description

It was reported that bd posiflush¿ xs pre-filled flush syringe nacl 0.9% had foreign matter inside.This was discovered before use.The following information was provided by the initial reporter: new, dirty bd saline xs syringes.

Manufacturer Narrative

The following fields were updated due to additional information: device available for eval yes, returned to manufacturer on: 2020-05-21.Investigation summary: a device history record review was performed for provided lot number 9248141 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, both picture and physical samples were provided for evaluation by our quality team.Through examination of the samples, the presence of foreign matter/brown stains on the product packaging was confirmed.It has been determined that the staining is a result of the steam sterilization process.The integrity of the product and the sterile barriers have not been affected.These spots appear only on the outside of the packaging and do not permeate in any way onto the product.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¿ xs 10ml saline flush syringe.We are currently exploring several options to reduce and eliminate any brown staining that occurs on the packaging.

• Brand Name: BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%
• Type of Device: NA
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 10045746
• MDR Text Key: 204181507
• Report Number: 9616657-2020-00073
• Device Sequence Number: 1
• Product Code: NGT
• 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: 05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 306572
• Device Lot Number: 9248141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2020
• Initial Date Manufacturer Received: 04/20/2020
• Initial Date FDA Received: 05/11/2020
• Supplement Dates Manufacturer Received: 04/20/2020
• Supplement Dates FDA Received: 05/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other