MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 20 ML BD LUER-LOK SYRINGE; PISTON SYRINGE

Catalog Number 301031

Device Problems Break (1069); Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944); Material Protrusion/Extrusion (2979)

Patient Problem No Patient Involvement (2645)

Event Date 04/23/2020

Event Type  malfunction  

Manufacturer Narrative

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 prior to use there were 202 occasions of foreign matter (black and white dots) and 97 damaged syringes with a 20 ml bd luer-lok¿ syringe.The following information was provided by the initial reporter: it was reported that 202 syringes have black and white dots, and 97 syringes are damaged.

Manufacturer Narrative

The following fields were updated due to additional information: d.10 device available for eval yes, returned to manufacturer on: 2020-05-21.H.6.Investigation summary: ten samples were received for evaluation.Visual inspection was performed.One sample has black specks embedded foreign matter on the barrel of the syringe.The other nine samples have one of the plunger rod ribs damaged.These are the ones shown in the photos.It may have happened that a jam occurred, and the plunger rod rib got damaged and not detected in the next processes.Five photos were provided for evaluation.One photo show two barrels with multiple black specs and smeared ink.The other photos show plunger rods rib damaged.These are the same photos provided for the complaint (b)(4).A potential root-cause for the embedded foreign matter can be attributed to the shield molding process.Embedded foreign matter can occur at the startup of an injection mold/press or intermittently during the injection molding process.Degraded resin inherently builds up in the barrel and hot-runner system of the mold and press.The degraded resin can break loose and be molded into components.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.H3 other text : see h.10.

Event Description

It was reported that prior to use there were 202 occasions of foreign matter (black and white dots) and 97 damaged syringes with a 20 ml bd luer-lok¿ syringe.The following information was provided by the initial reporter: it was reported that 202 syringes have black and white dots, and 97 syringes are damaged.

• Brand Name: 20 ML BD LUER-LOK SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 10089584
• MDR Text Key: 199892023
• Report Number: 1911916-2020-00487
• 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: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 301031
• Device Lot Number: 9303745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2020
• Date Manufacturer Received: 05/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other