MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD 10ML SYRINGE LUER-LOK TIP BULK CONVENIENCE PAK; PISTON SYRINGE

Catalog Number 309604

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 01/27/2021

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 the bd 10ml syringe luer-lok¿ tip bulk convenience pak experienced foreign matter in the device cannula/needle/syringe or other fluid path component.The following information was provided by the initial reporter: material no: 309604, batch no: unknown.A nurse had opened this fresh to pull saline off an iv bag and noticed a black hard chunk in the syringe.The nurse did not proceed to use the syringe.As the syringe sat with minimal saline in the syringe the hard chunk liquified and presented with the dark.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-02-11 h6: investigation summary one photo and one loose 10ml syringe was received and evaluated.It was observed there was multiple small dark red/black foreign matter particles inside the fluid path.The composition of the particles could not be visually determined.Fourier transform infrared spectroscopy was performed, the spectral analysis shows that this material is most likely blood.Lot number is unknown; therefore lot history could not be performed.Potential root cause for the foreign matter defect could not be determined.Since root cause could not be defined, no corrective actions are necessary at this time.See h10.

Event Description

It was reported that the bd 10ml syringe luer-lok¿ tip bulk convenience pak experienced foreign matter in the device cannula/needle/syringe or other fluid path component.The following information was provided by the initial reporter: material no: 309604 batch no: unknown a nurse had opened this fresh to pull saline off an iv bag and noticed a black hard chunk in the syringe.The nurse did not proceed to use the syringe.As the syringe sat with minimal saline in the syringe the hard chunk liquified and presented with the dark.

• Brand Name: BD 10ML SYRINGE LUER-LOK TIP BULK CONVENIENCE PAK
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 11363782
• MDR Text Key: 234679375
• Report Number: 1911916-2021-00150
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309604
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Initial Date Manufacturer Received: 01/27/2021
• Initial Date FDA Received: 02/23/2021
• Supplement Dates Manufacturer Received: 03/11/2021
• Supplement Dates FDA Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1