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

Catalog Number 306572

Device Problem Delivered as Unsterile Product (1421)

Patient Problem Sepsis (2067)

Event Date 09/21/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0154145.Medical device expiration date: 2023-05-31.Device manufacture date: 2020-06-02.Medical device lot #: 0160013.Medical device expiration date: 2023-05-31.Device manufacture date: 2020-06-08.(b)(4).A device history record review was performed for provided lot numbers 0154145 and 0160013.The review did not reveal any detected quality issues during the production process that could have directly contributed to this reported incident.All inspections, sterile barrier integrity tests, and bioburden tests were found to be within specification for both of the reported lot numbers prior to release of the product.As samples were unavailable for return, a thorough sample analysis could not be completed by our quality engineer team.Based on the provided information and investigation results, it is unlikely that the saline within the bd posiflush product was the contributory factor in the reported incident.Our quality team will closely monitor the production process for signs of any potential defects or emerging trends.Investigation conclusion: batch code: 0154145 - the non-conformances were reviewed for this batch, and there was no record of non-conformance which could contribute or is directly related to the complaint verbatim reported by the customer.Batch code: 0160013 - the non-conformances were reviewed for this batch, and there was no record of non-conformance which could contribute or is directly related to the complaint verbatim reported by the customer.There were no samples or photos returned.Root cause description: there is no evidence that posiflush syringe was responsible for the patients infection.Rationale: based on the information provided, it is unlikely that saline in the bd posiflush product was a contributory factor to the complaint of the patients infection.There are no other adverse customer complaint trends for this complaint category.See lab test memo attached for conclusion.A review of the applicable p-eura (10000046033 rev 3) indicates that the potential risk of the reported event was assessed appropriately in the risk management documentation.

Event Description

It was reported that the patient developed sepsis after using bd posiflush¿ xs pre-filled flush syringe nacl 0.9%.The sterility is being questioned.The following information was provided by the initial reporter: according to the customer, the patient has developed sepsis after the dietary solution was connected.We ask you to investigate whether the batch of bd posiflush may have been contaminated in order to exclude it as a cause.Unfortunately, there are no more samples available, since the customer has disposed them already.

• Brand Name: BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%
• Type of Device: SYRINGE
• 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 ; 8015652341
• MDR Report Key: 10653914
• MDR Text Key: 210588348
• Report Number: 9616657-2020-00160
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306572
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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