MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD POSIFLUSH SYRINGE 10ML SALINE FILL CE EMA/CIS SP; SALINE VASCULAR ACCESS FLUSH

Catalog Number 306585

Device Problem Material Opacification (1426)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/20/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

Event Description

It was reported that bd posiflush syringe 10ml saline fill ce ema/cis sp contents is 'turbid'.The following information was provided by the initial reporter: the patients describe that the product was turbid, and three patients vomited during use.

Event Description

Bd rep replied on 19-jan-2024.Could you please confirm why do they feel that the emesis is related to this event? = it was given to approximately 80 patients in during home care, all had a metallic aftertaste and three of them vomited.What treatment was provided for the emesis?: not found out.Was it self-limiting or was it a prolonged issue? = it was a short-lasting problem.What was the underlying diagnosis for each of the three patients?: the nurse called all approximately 80 patients.There were no complications with the other patients where a syringe from another manufacturer was used.What medication was being administered before the iv was flushed with this product?: not found out.

Manufacturer Narrative

A device history record review was completed for provided material number 306585 and lot number 3235050.The review identified two (2) quality notifications during the production process; however, all affected product was scrapped in both cases and no product was released to the market.There was no issues documented which could have affected the saline solution and all inspections and controls were reviewed and found to be acceptable.To aid in the investigation of this issue, two (2) shelf cartons of product were received for evaluation by our quality team.The samples were tested for appearance and solution clarity.As per the test results, there were no issues identified with solution clarity or appearance/syringe clarity.The test examines the appearance and solution clarity of the posiflush sp syringes and associated materials by comparing them to a solution of reference and a syringe of reference against two (2) types of backgrounds (black and white).The results show no saline solution clarity issues.The plastic material used to mold the barrel may be less transparent than others used by other manufacturing plants so it may seem the solution is cloudy.As per customer input, patients had a metallic aftertaste.As per the characteristic described, it could be associated with a distortion of the sense of taste, known as dysgeusia.Dysgeusia has been subject of a series of in-depth investigations by bd.In addition to biocompatibility testing, bd has conducted extensive chemical, biochemical, analytical, and biological testing of relevant materials.These investigations confirmed the absence of any significant risk to the patient¿s health following single or repeated exposure to bd posiflush¿ syringe contents.It was concluded that while unpleasant to the patient, this effect has no clinically relevant medical consequences.Bd posiflush¿ syringes continue to meet or exceed all standards applicable to these syringes.Bd fraga performs heavy metals tests for each lot number since dysgeusia could be related with a high presence of heavy metals in the saline solution.For the reported lot, all tests were accepted as per specification.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.

• Brand Name: BD POSIFLUSH SYRINGE 10ML SALINE FILL CE EMA/CIS SP
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18545093
• MDR Text Key: 333268295
• Report Number: 3002682307-2024-00007
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065851
• UDI-Public: (01)00382903065851
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: UKN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 306585
• Device Lot Number: 3235050
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/02/2024
• Initial Date FDA Received: 01/19/2024
• Supplement Dates Manufacturer Received: 04/23/2024
• Supplement Dates FDA Received: 05/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1