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

Catalog Number 306547

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 09/28/2023

Event Type  malfunction  

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.3.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 the bd posiflush¿ pre-filled saline syringe the plunger movement was difficult.The following was received by the initial reporter: the new lot # found at st.John¿s is 3214826.Flushing issue and resistance in plunger.

Event Description

No additional information.Material#: 306547.Lot#: 3214826.It was reported by the customer that flushing issue and resistance in plunger.Verbatim: the new lot # found at (b)(6) is 3214826.Related to (b)(4) and (b)(4).Flushing issue and resistance in plunger.

Manufacturer Narrative

(b)(4) follow up.On november 16, 2023, bd issued a product advisory for the bd posiflush saline syringe with general pump compatibility.Through customer complaints, bd confirmed that an incorrect stopper was used in nine lots of 10ml bd posiflush¿ normal saline flush syringes with general pump compatibility.The use of bd posiflush prefilled flush syringes, catalog number 306547, with this stopper causes an increase in injection force, which has the potential to trigger alarms if used with a syringe pump.The product has been validated and is acceptable for manual use per ifu (instructions for use).Bd has identified a root cause and initiated corrective actions to prevent recurrence of this issue.Please see the attached product advisory and follow the actions required.If you need any further assistance, please contact the north american regional complaint center.

• Brand Name: BD POSIFLUSH¿ PRE-FILLED 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: 17919651
• MDR Text Key: 325486692
• Report Number: 1911916-2023-00765
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065470
• UDI-Public: (01)30382903065470
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003553
• 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: 12/04/2023
• 2 Devices were Involved in the Event: 1 2

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: 306547
• Device Lot Number: 3214826
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2023
• Initial Date FDA Received: 10/12/2023
• Supplement Dates Manufacturer Received: 12/04/2023
• Supplement Dates FDA Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2023
• 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