MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306572

Device Problem Material Protrusion/Extrusion (2979)

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

Event Date 06/21/2023

Event Type  malfunction  

Event Description

It was reported that the tip of the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% had sharp molding defects on it.This occurred with an unspecified number of pre-filled syringes.The following information was provided by the initial reporter: "we have recently received a complaint from a healthcare professional pertaining to ¿bd posiflush xs 10 ml prefilled saline syringe, non sterile¿ (ref# (b)(4) , lot# not available/provided).The issue in question was described as follows: ¿bd makes a prefilled saline syringe that i discovered has a defect.On the tip there is often sharp remnants of plastic leaving an uneven surface on the syringe tip.The biomedical engineer thinks it is flashing or plastic molding left from the manufacturing die.I first discovered this in 2014 while working in the hospital.It inpacts the safety and integrity of the needleless connectors -'maxzero' (also made by bd) as it damages the smooth surface potentially being a source of bloodstream infection.It was reported to the company in 2014.I recently discovered it happening again.¿.The complainant additionally indicated that it had brought this matter to the attention of the manufacturer on (b)(6) 2014.They have not provided our office authorization to disclose their contact information.".

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.

Manufacturer Narrative

As neither a lot number nor a sample was available for this incident, a complete investigation could not be performed.Based on the limited investigation results, a cause for the reported incident could not be determined.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

Event Description

On 31-october-2023, no additional information provided: (b)(6).Material#:306572; batch#:unknown.It was reported by customer that on the tip there is often sharp remnants of plastic leaving an uneven surface on the syringe tip.The biomedical engineer thinks it is flashing or plastic molding left from the manufacturing die.They first discovered this in 2014 while working in the hospital.It impacts the safety and integrity of the needleless connectors -'maxzero' (also made by bd) as it damages the smooth surface potentially being a source of bloodstream infection.It was reported to the company in 2014.They recently discovered it happening again." verbatim: we have recently received a complaint from a healthcare professional pertaining to "bd posiflush xs 10 ml prefilled saline syringe, non sterile" (ref# (b)(4), lot# not available/provided).The issue in question was described as follows: "bd makes a prefilled saline syringe that i discovered has a defect.On the tip there is often sharp remnants of plastic leaving an uneven surface on the syringe tip.The biomedical engineer thinks it is flashing or plastic molding left from the manufacturing die.I first discovered this in 2014 while working in the hospital.It inpacts the safety and integrity of the needleless connectors -'maxzero' (also made by bd) as it damages the smooth surface potentially being a source of bloodstream infection.It was reported to the company in 2014.I recently discovered it happening again.¿ associated device identified as ¿maxzero needle-free connector¿ (ref# (b)(4), lot# not available/provided).The complainant additionally indicated that it had brought this matter to the attention of the manufacturer on 2014/01/22.They have not provided our office authorization to disclose their contact information.This notice serves to request submission of any investigative actions undertaken (along with associated findings) and corrective measures implemented in respect of this report as soon as possible.Additional info from customer: on (06-sep-2023): please accept my apologies for the timing of my reply as i have been away from the office.The only additional information which appears to have been provided by the complainant (beyond what was disclosed already in the original email notification to bd) is the "incident date" of (b)(6) 2023 and that the device was acquired as "an inventory item purchased through the hospital buying department".Our reference number for this matter remains incident #(b)(4).

• Brand Name: BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer (Section G): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17656407
• MDR Text Key: 323252528
• Report Number: 9616657-2023-00035
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/26/2023

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: 306572
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/30/2023
• Supplement Dates Manufacturer Received: 10/26/2023
• Supplement Dates FDA Received: 11/01/2023
• 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