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

Catalog Number 306546

Device Problem Difficult to Advance (2920)

Patient Problem Insufficient Information (4580)

Event Date 07/12/2023

Event Type  malfunction  

Event Description

It was reported the bd posiflush¿ normal saline syringe difficult to push the plunger down to flush an iv line.The following was received by the initial reporter: verbatim: they have recently experienced some difficulty with the 10ml bd posiflush saline syringe (ndc# 09290-3065-46) and have reported individual syringes where it is difficult to push the plunger down to flush an iv line.They have only provided one lot number so far ¿ 3047971 ¿ but said that this issue has occurred numerous times.I do have a single syringe in my possession if you would like to see it.

Manufacturer Narrative

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

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 24aug2023.Investigation summary: it was reported it is difficult to push the plunger down.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 per it287, which is the force applied to the plunger rod while moving downwards when expelling the saline solution, and the result was within specification.A device history record review was completed for provided material number 306546, lot 3047971.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 offered.

Event Description

It was reported the bd posiflush¿ normal saline syringe difficult to push the plunger down to flush an iv line.The following was received by the initial reporter: verbatim: they have recently experienced some difficulty with the 10ml bd posiflush saline syringe (ndc# 09290-3065-46) and have reported individual syringes where it is difficult to push the plunger down to flush an iv line.They have only provided one lot number so far ¿ 3047971 ¿ but said that this issue has occurred numerous times.I do have a single syringe in my possession if you would like to see it.

• 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: 17454679
• MDR Text Key: 320348413
• Report Number: 1911916-2023-00548
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/16/2023

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: Other
• Device Catalogue Number: 306546
• Device Lot Number: 3047971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2023
• Initial Date FDA Received: 08/03/2023
• Supplement Dates Manufacturer Received: 08/16/2023
• Supplement Dates FDA Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2023
• 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