MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH-XS / SF; SALINE VASCULAR ACCESS FLUSH

Catalog Number 306572

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 01/23/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

Event Description

It was reported that bd posiflush-xs / sf contains foreign matter.The following information was provided by the initial reporter, translated from german to english: heavy visible contamination in the syringe we were only informed that the contamination had been reported to the federal institute for drugs and medical technology.

Event Description

No additional information.

Manufacturer Narrative

A device history record review was completed for provided material number 306572 and lot number 3194284.The review did not reveal any detected non-conformances during the production process that could have contributed to this incident.To aid in the investigation of this issue, one (1) picture sample and thirteen (13) physical samples were returned for evaluation by our quality team.Of the returned syringes, one (1) was found to have foreign matter on the plunger rod.At this time, an exact cause could not be determined for the observed foreign matter.A corrective and preventive action plan has been initiated to further investigate this issue and prevent any reoccurrence.

• Brand Name: BD POSIFLUSH-XS / SF
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18691382
• MDR Text Key: 336405529
• Report Number: 9616657-2024-00006
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065721
• UDI-Public: (01)00382903065721
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/29/2024

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: 306572
• Device Lot Number: 3194284
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2024
• Initial Date FDA Received: 02/12/2024
• Supplement Dates Manufacturer Received: 04/29/2024
• Supplement Dates FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1