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

Catalog Number 306553

Device Problems Device Damaged Prior to Use (2284); Device Packaging Compromised (2916)

Patient Problem No Patient Involvement (2645)

Event Date 12/19/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation: based on the investigation of the reported issue, the root cause is determined to be related to the sterilization process.The staining occurs as a result of the interaction between the paper and the moist heat sterilization process.It appears only on the outside of the packaging and does not permeate in any way onto the product.Test results have confirmed the stains do not present any risk to the use of the product and have no impact on the effectiveness, sterility, quality or safety; it is cosmetic only.In response to the increasing amount of staining presence, a corrective and preventive action plan has been initiated to address the staining associated with this particular blister top web packaging material.The corrective and preventive action plan is in the investigation process and our quality team is gathering and interpreting data at this time.Investigation activities: 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.Exceptions: lot numbers manufactured prior to lot 6315951 may have associated staining complaints as a result of sterilizer component issues.This was addressed in capa (b)(4) and the associated corrective action was implemented november 2016.Lot number 6315951 was the first lot number manufactured post corrective action implementation.Lot numbers prior to lot 6315951 may generate customer complaints for staining, these complaints are not within scope of this pic and shall be addressed on an individual basis.Root cause: based on the investigation of the reported issue, the root cause is determined to be related to the sterilization process.The staining occurs as a result of the interaction between the paper and the moist heat sterilization process.

Event Description

It was reported that a shipment of bd posiflush¿ sf saline syringe(s) arrived with water marks on the outside of syringe packaging making it impossible to ascertain the efficacy and sterility of the contents.This was observed before use and there was no report of injury or medical intervention.

Manufacturer Narrative

After further evaluation, it was determined that this incident is not mdr reportable.The complaint by the customer stated that the outside of the syringe packaging contained water marks, making it impossible to ascertain sterility.However, according to our position on reporting prefilled saline flushes for sterility breach, it is only reportable if the cap is off the device, which was not the case for this incident.

• Brand Name: BD POSIFLUSH¿ SF SALINE SYRINGE
• Type of Device: SALINE FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer (Section G): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7162311
• MDR Text Key: 96465080
• Report Number: 9616657-2017-00020
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065531
• UDI-Public: 30382903065531
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/08/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2017
• Initial Date FDA Received: 01/03/2018
• Supplement Dates Manufacturer Received: 12/19/2017
• Supplement Dates FDA Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other