MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ NORMAL SALINE SYRINGE; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306575

Device Problem Material Separation (1562)

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

Event Date 09/12/2023

Event Type  malfunction  

Event Description

It was reported while using the bd posiflush¿ normal saline syringe, the plunger was damaged.The following was received from the initial reporter: details of complaint (reported issue): writer used bd 0.9% sodium chloride injection, usp 10ml prefilled syringe to flush cvad lumen and to draw discard for blood work.During this action the clear plunger became removed from the syringe.Thankfully the black part of the plunger remained in the syringe therefore not causing a contaminant risk to the patient.Writer had been using syringe in an appropriate manner, not having any difficulty or having to use any force when the plunger popped out of the syringe.Complaint noticed: during / after use.Problem frequency: 1st time.Customer exposure: patient injury: no.

Manufacturer Narrative

H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H6: investigation summary: as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.There are current quality controls in place to detect this type of defect during the production process.Based on the limited investigation results, a cause for the reported incident could not be determined.A device history review could not be completed as no batch number was provided.

Event Description

It was reported while using the bd posiflush¿ normal saline syringe, the plunger was damaged.The following was received from the initial reporter: details of complaint (reported issue): writer used bd 0.9% sodium chloride injection, usp 10ml prefilled syringe to flush cvad lumen and to draw discard for blood work.During this action the clear plunger became removed from the syringe.Thankfully the black part of the plunger remained in the syringe therefore not causing a contaminant risk to the patient.Writer had been using syringe in an appropriate manner, not having any difficulty or having to use any force when the plunger popped out of the syringe.Complaint noticed: during / after use.Problem frequency: 1st time.Customer exposure: patient injury: no.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17868041
• MDR Text Key: 324881487
• Report Number: 1911916-2023-00726
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065752
• UDI-Public: (01)00382903065752
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/09/2023

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2023
• Initial Date FDA Received: 10/04/2023
• Supplement Dates Manufacturer Received: 10/09/2023
• Supplement Dates FDA Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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