MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD¿ POSIFLUSH¿ SALINE XS 10 ML; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306572

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

Patient Problem Pain (1994)

Event Date 06/19/2023

Event Type  Injury  

Event Description

It was reported that while using the bd¿ posiflush¿ saline xs 10 ml the patient had pain.The following information was provided by the initial reporter: verbatim: we have received complaint (b)(4) (bd saline filled 10ml syringe xs), lot 2269042 in relation to ¿pain experienced during the use of product¿.Our customer stated, ¿when administrating the 0.9% nacl flush, the pt reported a sharp pain on their right chest, on the 1st 1ml, i said i would try again, patient had the same pain on second ml, i asked if i could try again but slower, patient agreed administrated 3rd ml slowly, patient still had sharp pain.Stopped flushing the line, not safe to use, advised patient to go to hospital to check the patency of the line.Because of this the patient did not receive their prescribed fluids and multi-vitamins.¿.

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.E.1.Initial reporter phone #: (b)(6).H.6.Investigation summary: a device history record review was completed for provided material number 306572 and lot number 2269042.The review did not reveal any possible non-conformances which could have contributed to this incident.As samples were unavailable for return, a thorough sample analysis could not be performed.As per product specifications, the composition/ingredients for this product consists of sodium chloride dissolved into water for injection, to produce a 0.9% sodium chloride solution.This product is not made with natural rubber latex or preservatives.This product is non-toxic and non-pyrogenic.Multiple in-process and finished product tests and inspections are performed to ensure that the product is fit for its intended use and meets the standard requirements.At this time, further action has not been determined necessary.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.H3 other text : see h.10.

• Brand Name: BD¿ POSIFLUSH¿ SALINE XS 10 ML
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer (Section G): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17321747
• MDR Text Key: 319184181
• Report Number: 9616657-2023-00024
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 306572
• Device Lot Number: 2269042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2022
• 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