MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK 20 ML SYRINGE; PISTON SYRINGE

Model Number 300613

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/30/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd plastipak¿ 20 ml syringe had molding defects.This occurred on 3 occasions during use.The following information was provided by the initial reporter: poor cutting of plastic handles (raw edges), resulting in cuts by medical staff.

Manufacturer Narrative

H.6.Investigation summary: three samples and one photo were provided to our quality team for investigation.The product was visually inspected, burrs were observed along the plunger.This defect can be caused during the molding process.A device history review was performed for reported lot 1907298, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.The areas where pieces run in manufacturing equipment are protected to avoid damage on the product.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.Based on the available information we cannot identify a definitive root cause at this time.Complaints received for this defect and device will be monitored by our quality team for signs of emerging trends.

Event Description

It was reported that bd plastipak¿ 20 ml syringe had molding defects.This occurred on 3 occasions during use.The following information was provided by the initial reporter: poor cutting of plastic handles (raw edges), resulting in cuts by medical staff.

• Brand Name: BD PLASTIPAK 20 ML SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 9826052
• MDR Text Key: 210632090
• Report Number: 3003152976-2020-00126
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903006138
• UDI-Public: 30382903006138
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• 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: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 300613
• Device Catalogue Number: 300613
• Device Lot Number: 1907298
• Date Manufacturer Received: 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other