MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 10ML SALINE FILL CE; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306575

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/29/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.H3 other text : see h10 manufacture narrative.

Event Description

Impurities found in posiflush after diluting antibiotics.No patient harm.

Manufacturer Narrative

A device history record review was completed for provided material number 306575 and lot number 3199057.The review did not reveal any detected abnormalities during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, one (1) picture sample was received for evaluation by our quality team.Through examination of the picture, a dark spot on the barrel label was observed on the syringe.Through the picture sample alone, it is not clear if the spot is within the solution or what the spot composition is.It is also unknown if the particle was already in the solution prior to diluting with antibiotics, if it appeared after the dilution, or if the syringe was used to aspirate.As the affected sample was not available for return, retained samples of the same lot number were obtained from the manufacturing facility.The retained samples did not reveal any particulates.At this time an exact cause related to the manufacturing process could not be determined for this incident.Bd posiflush sp syringes are intended to be used for flushing only of in-situ peripheral intravenous catheters (pivcs), peripherally inserted central catheters (piccs), central venous catheters (cvcs),and implanted venous access ports.Bd posiflush sp is not intended for dry product reconstitution, for medication dilution, or where intravenous therapy with sodium chloride is indicated.The syringe consists of a ready to use syringe, which is pre-filled with an injectable sterile non-pyrogenic and isotonic 0.9% sodium chloride solution.The syringe is not to be re-sterilized or re-used.There is a misuse of the syringe as it was used to dilute antibiotics and there is the possibility of contamination of the saline solution.The bd manufacturing process has several preventive measures in place to prevent contamination of the saline solution including inspections and routine washes of the filling area.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: SYRINGE 10ML SALINE FILL CE
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• 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: 18624259
• MDR Text Key: 334335597
• Report Number: 1911916-2024-00050
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065752
• UDI-Public: (01)00382903065752
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K003553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/29/2024

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: Health Professional
• Device Catalogue Number: 306575
• Device Lot Number: 3199057
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2024
• Initial Date FDA Received: 02/01/2024
• Supplement Dates Manufacturer Received: 04/29/2024
• Supplement Dates FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1