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

Catalog Number 306553

Device Problem Packaging Problem (3007)

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

Event Date 01/30/2018

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.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 306553, medical device expiration date:2020-05-31, device manufacture date: 2017-06-19, medical device lot #: 7180928, medical device expiration date: 2020-05-31, device manufacture date: 2017-06-29, medical device lot #: 7244896, d.4.Medical device expiration date: 2020-08-31, device manufacture date: 2017-09-01.

Event Description

It was reported that before use a bd posiflush¿ sf saline syringe was found with package integrity as ¿faint fluid stains can be visualized on both the outside and inside of the packaging." there was no report of exposure, injury or medical intervention needed.

Manufacturer Narrative

Investigation summary: lot review for 7170621, 7180928, 7244896 the non-conformances were reviewed for the above batches; there were no non-conformances that may be associated with this defect.Risk assessment: in 2017, for this defect type, complaints were reported at an average of 3 per month.(b)(4).Severity is negligible (s1).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.Investigation conclusion: 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.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.; donore road; drogheda
• MDR Report Key: 7293659
• MDR Text Key: 101014593
• Report Number: 9616657-2018-00009
• 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: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306553
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Date Manufacturer Received: 01/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other