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

Catalog Number 306553

Device Problem Material Discolored (1170)

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

Event Date 04/12/2018

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 with the use of the bd posiflush¿ sf saline syringe there was an issue with the discoloration on the packaging compromising sterility.It was stated ¿the product packaging was discolored.The consumer was inquiring if the product is safe to use¿ there was no report of injury or further medical intervention.

Manufacturer Narrative

Investigation summary: bd recently received an increase in complaints related to ¿brown staining¿ on the outer packaging of the bd posiflushtm sf 10ml saline flush syringe (product code: 306553).Our team investigated the staining on the outer packaging and determined that this is a cosmetic issue only.These products are safe for use.The integrity of the product and the sterile barrier has not been affected.The brownish spots on the packaging were created during the steam sterilization process.Thorough testing confirmed that the brownish spots do not present any risk to the use of the products and have no impact on the effectiveness, sterility, quality or safety of the bd posiflushtm sf 10ml saline flush syringe.The review of the lot dhr did not indicate any anomaly which could have contributed to this issue.Risk assessment: in 2017, for this defect type, complaints were reported at an average of 3 per month.Occurrence rate varies between customers, but a total of 26 have been recorded for this specific defect from january to august 2017.Severity is negligible (s1).Investigation activities: samples not required as complaint has been previously investigated.The brown staining present on the sf paper top web was observed and reported during the design verification activities.Test results have confirmed the staining to be cosmetic in nature.Samples were shared with customers prior to product launch and the physical appearance of the product was accepted by the customer.The staining occurs as a result of the interaction between the paper and the moist heat sterilization process.Investigation conclusions: the water mark type staining is cosmetic in nature, appears only on the outside of the packaging and does 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 sf 10ml saline flush syringe.Corrective action: required.Capa (b)(4) has been raised following unit level discussions in september 2017.

• Brand Name: BD POSIFLUSH¿ SF SALINE SYRINGE
• Type of Device: SALINE FLUSH
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• MDR Report Key: 7451516
• MDR Text Key: 106715710
• Report Number: 9616657-2018-00018
• 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: 05/02/2018

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: 05/31/2020
• Device Catalogue Number: 306553
• Device Lot Number: 7180928
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/12/2018
• Initial Date FDA Received: 04/23/2018
• Supplement Dates Manufacturer Received: 04/12/2018
• Supplement Dates FDA Received: 05/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other