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 Separation (1562)

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

Event Date 10/19/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% stopper separated from the plunger.The following information was provided by the initial reporter: "we have a faulty product which when used on a patient the syringe disconnected between the rubber end and the barrel.".

Event Description

It was reported that the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% stopper separated from the plunger.The following information was provided by the initial reporter: "we have a faulty product which when used on a patient the syringe disconnected between the rubber end and the barrel.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 12-dec-2022.A device history record review was completed for provided material number 306572 and lot number 2070055.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.To aid in the investigation of this issue, one picture sample and one physical sample were returned for evaluation by our quality engineer team.The syringe had been removed from the original blister packaging and was fully dispensed with contamination at the tip.Inspection of the syringe confirmed that the plunger rod had separated from the stopper component.Based on the investigation results, an exact cause related to the manufacturing process could not be determined for this incident.It is possible that the separation resulted from misuse.It is important to note that the posiflush syringes are pre-filled single use syringes intended for flushing.At this time, further action has not been determined necessary.H3 other text : see h10.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15788805
• MDR Text Key: 307597882
• Report Number: 9616657-2022-00037
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065721
• UDI-Public: (01)00382903065721
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306572
• Device Lot Number: 2070055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2022
• 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