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

Catalog Number 306572

Device Problems Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Sepsis (2067)

Event Date 08/06/2020

Event Type  Injury  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the patient is fighting sepsis.The patient's mother is wondering if the recalled bd posiflush¿ xs pre-filled flush syringe nacl 0.9% could be contributing to the infection.The following information was provided by the initial reporter: chap0349, 306572, pfs 0.9%p/flush xs saline 10 ml st 9248167.Patient¿s mother reports the patient has been in hospital fighting line sepsis, patient¿s mother would like to know if this could be related to the pfs recall.9248167 is the only recalled batch sent to the patient.

Manufacturer Narrative

H.6.Investigation summary a device history record review was performed for provided lot number 9248167 and the review did not reveal any quality issues that could have contributed to this reported incident.The lab testings were reviewed for this lot number and all test results for this product met the standard requirements for intended use prior to release.There is no evidence that the posiflush syringe would have been responsible for an infection.Our quality team will closely monitor the production process for any signs of potential defects or emerging trends.

Event Description

It was reported that the patient is fighting sepsis.The patient's mother is wondering if the recalled bd posiflush¿ xs pre-filled flush syringe nacl 0.9% could be contributing to the infection.The following information was provided by the initial reporter: chap0349 306572 pfs 0.9%p/flush xs saline 10ml st 9248167 patient¿s mother reports the patient has been in hospital fighting line sepsis, patient¿s mother would like to know if this could be related to the pfs recall.9248167 is the only recalled batch sent to the patient.

• 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: 10463627
• MDR Text Key: 205481338
• Report Number: 9616657-2020-00134
• 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: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• 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: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention