MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%; PREFILLED SALINE SYRINGE

Catalog Number 306574

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

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/12/2020

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.(b)(4).

Event Description

It was reported that foreign matter "a bug" was discovered with a bd posiflush¿ xs pre-filled flush syringe nacl 0.9%.The following information was provided by the initial reporter: the nurse picked the plastic outside away and when she looked into the syringe she saw a black thing in the saltwater.It looks like a bug.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 1/7/2021.H.6.Investigation: a device history record review was completed for provided lot number 9303749.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.To aid in the investigation of this issue, the affected sample was returned for evaluation by our quality engineer team.Through examination of the sample, a particle was observed suspended within the saline solution.The sample was then sent for fourier-transform infrared spectroscopy analysis to identify the particle composition.The analysis revealed that the foreign matter was most likely composed of hair fibers.An exact cause during the manufacturing process cannot be identified for this incident.However, it is possible that the foreign matter was introduced during the bulk production process or at the filler machine due to a potential incorrect use of the required protective clothing.

Event Description

It was reported that foreign matter "a bug" was discovered with a bd posiflush¿ xs pre-filled flush syringe nacl 0.9%.The following information was provided by the initial reporter: the nurse picked the plastic outside away and when she looked into the syringe she saw a black thing in the saltwater.It looks like a bug.

• Brand Name: BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%
• Type of Device: PREFILLED SALINE SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• MDR Report Key: 10973455
• MDR Text Key: 220452328
• Report Number: 3002682307-2020-00394
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 306574
• Device Lot Number: 9303749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• Date Manufacturer Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1