MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD POSIFLUSH¿ NORMAL SALINE SYRINGE; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306575

Device Problem Difficult to Advance (2920)

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

Event Date 05/27/2023

Event Type  malfunction  

Manufacturer Narrative

D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H6.Investigation summary: as a lot number was unknown for this incident, we were unable to complete a production history review and unable to identify if any previous reports have been received for the affected lot regarding this type of defect.Without the physical sample, our quality team was not able to complete a thorough analysis.Based on the limited investigation results, an exact cause related to the manufacturing process for the reported issue could not be determined.Examination of the product or lot involved in this incident may provide clarification for the cause of this reported failure.Complaints received for this product and defect will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.H3 other text : see h.10.

Event Description

It was reported while using bd posiflush¿ normal saline syringe the plunger was difficult to move.The following information was provided by the initial reporter: new episode on the same shift (27th may) "when the contact person (omit) talked to the nurses again it appeard that also another nurse experienced the same problem so i have 2 cases from the same shift.Nurse 2, no sample available; flushed a cvc and the plunger stopped at approx.2-3ml remaining in the syringe.Was there any negative impact on the patient? in this case no.The nurse took a new posiflush and the cvc was flushed.For this case, lot is unknown, the nurse didn¿t save the sample.They assume it could be from the same lot but cannot be sure.".

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17211323
• MDR Text Key: 318182339
• Report Number: 3002682307-2023-00171
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065752
• UDI-Public: (01)00382903065752
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/07/2023

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: 06/02/2023
• Initial Date FDA Received: 06/27/2023
• 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