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

Catalog Number 306553

Device Problems Material Discolored (1170); Packaging Problem (3007)

Patient Problem No Information (3190)

Event Date 05/01/2018

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 the bd posiflush¿ sf saline syringe package has water stains and some are faint stains.Found before use.No reports of serious injury or medical intervention noted.

Manufacturer Narrative

Investigation summary: seven picture samples were received for evaluation by our quality engineer team.Upon examination of the pictures, discoloration was observed on the packaging.A device history record review revealed no anomalies during the production of the provided lot number that could have contributed to this issue.Microbial permeability testing, cytotoxicity testing, and testing for residual solvents and volatile species has been completed on the packages displaying the brownish stains.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 posiflushtm sf 10ml saline flush syringe.This is a cosmetic issue only.These products are safe for use.The integrity of the product and the sterile barriers has not been affected.The brownish spots on the packaging were created during the steam sterilization process.These spots appear only on the outside of the packaging and do not permeate in any way onto the product.We are currently exploring several options to reduce and eliminate any brown staining that occurs on the packaging.The product continues to be safe for use.Capa: (b)(4) has been raised to deal with the staining issue.

• Brand Name: BD POSIFLUSH¿ SF SALINE SYRINGE
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 7515846
• MDR Text Key: 108492149
• Report Number: 9616657-2018-00021
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065530
• UDI-Public: 00382903065530
• 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: 05/29/2018

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: 08/31/2020
• Device Catalogue Number: 306553
• Device Lot Number: 7244896
• Initial Date Manufacturer Received: 05/01/2018
• Initial Date FDA Received: 05/15/2018
• Supplement Dates Manufacturer Received: 05/01/2018
• Supplement Dates FDA Received: 05/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other