MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSHIFLUSH SP; SALINE, VASCULAR ACCESS FLUSH

Model Number 306546

Device Problem Defective Component (2292)

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

Event Date 06/22/2023

Event Type  malfunction  

Manufacturer Narrative

H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that while using bd poshiflush sp the rubber stopper inside the syringe does not move easily against the plastic so it is difficult to flush.Report 2 of 2.The following information was provided by the initial reporter: verbatim: the rubber stopper inside the syringe does not move easily against the plastic so it¿s difficult to flush.The first time we encountered it we actually thought there was something wrong with the iv site that we had just started and thought we needed to stick the patient again before trying another flush and realizing the issue was with the flush itself.Patient was safe, no injuries.

Manufacturer Narrative

H6: investigation summary it was reported the rubber stopper inside the syringe does not move easily against the plastic, so it is difficult to flush the syringe.To aid in the investigation, one empty sample with no packaging flow wrap, or tip cap, was received for evaluation by our quality team.A visual inspection was performed, and no defects or imperfections were observed.The sample was then tested for sustaining force, which is the force applied to the plunger rod while moving downwards when expelling the saline solution, per it287and the result was within specification.A device history record review was completed for provided material number 306546, lot 2227032.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed and a probable root cause could not be determined.H3 other text : see h10.

Event Description

It was reported that while using bd poshiflush sp the rubber stopper inside the syringe does not move easily against the plastic so it is difficult to flush.Report 2 of 2.The following information was provided by the initial reporter: verbatim: the rubber stopper inside the syringe does not move easily against the plastic so it¿s difficult to flush.The first time we encountered it we actually thought there was something wrong with the iv site that we had just started and thought we needed to stick the patient again before trying another flush and realizing the issue was with the flush itself.Patient was safe, no injuries.

• Brand Name: BD POSHIFLUSH SP
• 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17313655
• MDR Text Key: 319493854
• Report Number: 1911916-2023-00481
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065463
• UDI-Public: (01)30382903065463
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 306546
• Device Catalogue Number: 306546
• Device Lot Number: 2227032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1