MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ NORMAL SALINE SYRINGE, IN 10 ML SYRINGE; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306547

Device Problem Difficult to Flush (1251)

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

Event Date 09/21/2023

Event Type  malfunction  

Event Description

It was reported while using bd posiflush¿ normal saline syringe, in 10 ml syringe the plunger was difficult to move.There was no report of patient impact.The following information was provided by the initial reporter: they did sequester lot# 3226386 but now are experiencing similar issues with 2 other lots 3207555 & 3214828.These were tested by our practice and education team and said they are very hard to push.Could the lots starting with 32 have experienced issues in manufacturing? when the rep comes on site they can test them to see what our clinicians are experiencing.

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d4.Medical device lot #: 3207555.D4.Medical device expiration date: 31jul2026.H4.Device manufacture date: 26jul2023.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

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.

Event Description

Mat#: 306547 batch#: 3207555 & 3214828 it was reported by the customer that product very hard to push.Verbatim : hi kim, they did sequester lot# 3226386 but now are experiencing similar issues with 2 other lots 3207555 & 3214828.These were tested by our practice and education team and said they are very hard to push.Could the lots starting with 32 have experienced issues in manufacturing? when the rep comes on site they can test them to see what our clinicians are experiencing.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE, IN 10 ML 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 ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17872890
• MDR Text Key: 325100903
• Report Number: 1911916-2023-00730
• Device Sequence Number: 1
• Product Code: FOZ
• 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: Other
• Device Catalogue Number: 306547
• Device Lot Number: 3214828
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2023
• Initial Date FDA Received: 10/04/2023
• Supplement Dates Manufacturer Received: 12/04/2023
• Supplement Dates FDA Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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