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

Catalog Number 306572

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 06/03/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation summary: a device history record review was performed for provided lot number 9255888 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.As samples were unavailable for return, out quality engineer team was unable to complete a thorough sample investigation.Based on the provided information, there is no evidence to support that the posiflush syringe was responsible for the reported infection.A potential contributory factor may have been the other medicinal products in use or administered at the time the patient's port was flushed.During the period of 2017-2019, there were no other adverse reaction trends for customer complaints related to allergic reactions or infections.A field safety notice (fsn) was recently communicated regarding this product line; however, the lot number involved in this incident was not involved in the fsn.This lot number was produced on a separate manufacturing line than the product involved in the communicated fsn.Investigation conclusion: batch code: 9255888.The non-conformances were reviewed for this batch, and there was no record of non-conformance which could contribute to the complaint verbatim reported by the customer.There were no samples returned.Based on the information provided, it is unlikely that any of the above are a contributory factor to the complaint verbatim reported by the customer.Root cause description: there is no evidence that posiflush syringe was responsible for this infection.A potential contributory factor maybe other medicinal products in use or administered at the time the patient¿s port was flushed.Rationale: based on the information provided, it is more probable than not that the symptoms described may be infection related; it is highly improbable that this infection was not produced by the normal saline in the bd posiflush product.During the period 2017-2019, there are no other adverse customer complaint trends for the complaint category of allergic reaction/infection there are no known allergies to normal saline, either topical or within the body.The batch referenced in this complaint is not involved in the fsn communicated recently.

Event Description

It was reported that the patient got an infection after using bd posiflush¿ xs pre-filled flush syringe nacl 0.9%.The following information was provided by the initial reporter: this issue involved your correspondence with us in (b)(6) regarding the field safety notice; we fed this out the patient who formally queried if this was a potential cause of the issues that he has had with his hickman line / infection with led him to going in to hospital.Patient called regarding the faulty posiflush.He received a letter to say that some of the posiflush have been affected.He advised he has just gotten out of hospital regarding issues with his hickman line and he had an infection.

Event Description

It was reported that the patient got an infection after using bd posiflush¿ xs pre-filled flush syringe nacl 0.9%.The following information was provided by the initial reporter: this issue involved your correspondence with us in april regarding the field safety notice; we fed this out the patient who formally queried if this was a potential cause of the issues that he has had with his hickman line / infection with led him to going in to hospital.Patient called regarding the faulty posiflush.He received a letter to say that some of the posiflush have been affected.He advised he has just gotten out of hospital regarding issues with his hickman line and he had an infection.

Manufacturer Narrative

The following fields have been updated with corrections: medical device expiration date: 2022-08-31; medical device lot #: 9248167; device manufacture date: 2019-09-05.

• 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
• MDR Report Key: 10195666
• MDR Text Key: 201069238
• Report Number: 9616657-2020-00098
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 306572
• Device Lot Number: 9248167
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention